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Philips Defibrillator Recall

There have been two different recalls with Philips AEDs in the last few years. This article was previously published regarding the 2018 recall but we now have updated it to include the February 2022 recall as well. We will unpack details for each recall.

PHILIPS COMPANY STATEMENT 2022 Recall

February 2022

Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). 

Through its post-market surveillance, Philips has identified that for affected pads, some gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. 

When a pad with separated, folded gel is placed on the patient’s bare skin, the HS1 AED could deliver less effective or ineffective therapy to the patient due to the reduced surface contact area with the skin. As affected pads are stored in sealed cartridges, this issue will not be visible until the cartridge is opened for use. 

Users should continue to use the HS1 AED and pads as-is, and follow the device’s voice prompts during use, because the AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HS1 AED in service according to the Instructions for Use/Owner’s Manual and the field safety notice. 

Philips is actively working on design changes to eliminate this issue in the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge, and projects new pad availability later in 2022. The company will notify affected customers when the new design pad is available. 

This issue only relates to HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) and does not involve HeartStart FRx. 

FREQUENTLY ASKED QUESTIONS 

Q: What is an AED? 

A: An automated external defibrillator (AED} is a device that checks a person’s heart and delivers an electric shock if it has stopped beating normally. 

Q: What are the HSl, OnSite, and Home AEDs? 

A: The HSl, OnSite, and Home AEDs are medical devices that audibly prompt the user to take specific actions if a potentially shockable rhythm is detected. These AEDs use defibrillation pads placed on the victim’s skin to deliver a shock. Once the defibrillation pads are placed on the patient, it analyzes the heart rhythm, determine whether or not a shock is required, charges the capacitor, and indicates to deliver a shock. The HSl, OnSite, and Home AEDs are able to provide verbal instructions to the user, detect where the user is in the event response, and provide general CPR guidance. 

Q: Who uses the HSl, OnSite, and Home AEDs? 

A: The HSl, OnSite, and Home AEDs are designed for use by a layperson. 

Q: Which pads can be used with the HSl, OnSite, and Home AEDs for defibrillation? 

A: The Adult SMART Pads Cartridge [REF: MS071A] and the Infant/Child SMART 

Pads Cartridge [REF: MS072A] may be used with the HSl, OnSite, and Home AEDs for defibrillation. 

Q: Does this Medical Device Correction affect any other HeartStart pads? 

A: No. This Medical Device Correction only affects the M5071A (Adult) and M5072A (Infant/Child) pads cartridges used with the HSl, OnSite, and Home AEDs. 

Q: Is there a possibility of patient harm? 

A: Users should continue to use the HSl/OnSite/Home AED and pads as-is, and follow the device’s voice prompts during use, because the AED will audibly guide users through each step of the procedure. 

In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patient’s skin. Should this occur, there is a possibility of insufficient therapy delivery or patient skin burns. There is also the potential for delayed therapy if the appearance of the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads.  

Q: Will all unexpired MS071A and MS072A pads experience this problem? 

A: No. At the time of the issuance of the February 2022 notification, Philips has received 115 reports about this issue since 2010 out of approximately 5 million shipments of M5071A and M5072A pads. (Most of these reports, approximately 84, were received in 2021.) 

Q:     Is it possible to know prior to patient use if my pad will experience gel separation?

A:   It is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. 

Q:     Is there any concern with M5071A and M5072A pads that do not experience gel separation?

A:     M5071A and M5072A pads that do not experience gel separation during use are not of concern.

Q:    Is there any concern with M5071A and MS072A pads that have a discolored, melted appearance?

A:   A discolored, melted appearance does not have any impact on the delivery of therapy; however, there may be a delay in therapy if the user hesitates to apply the pad due to its appearance. Do not hesitate to apply discolored, melted pads to the patient unless the gel has almost completely separated from the backing. No matter the state of the pads, the HSl/OnSite/Home AED voice prompts will audibly guide the user through each step of the procedure.

Q:     What should I do with my MS071A and M5072A pads?

A: ·  Continue using the pads as-is. Ensure that your HSl/OnSite/Home AED has a pads cartridge installed and that the green Ready light is flashing per the Instructions for Use/Owner’s Manual. During use, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. If you notice the gel beginning to separate from the foam backing as you peel, try to prevent the gel from folding onto itself if possible. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the backing. In case of trouble, install spare pads if available and continue the rescue. No matter the state of the pads, the HSl/OnSite/Home AED voice prompts will audibly guide the user through each step of the procedure.

Q:     Can M5071A and MS072A pads be installed in HSl/OnSite/Home?

A:     Yes. Ensure that your HSl/OnSite/Home AED has a pads cartridge installed and that the green Ready light is flashing per the Instructions for Use/Owner’s Manual.

Q:   Should I store a spare pads cartridge with my HSl/OnSite/Home AED?

A:     As described in the IFU, it is recommended that you store a spare pads cartridge with your HSl/OnSite/Home AED. A short video showing how to replace the pads cartridge can be found at: www .philips.com/ replace-ae d-pads-video 

Q:    What if I notice gel separation occur during use?

A:   During use, if you notice the gel beginning to separate from the foam backing, try to prevent the gel from folding onto itself if possible. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the foam/tin backing. However, if the gel has almost completely separated from the backing, replace the pads cartridge if a spare is available. If no spare is available, perform CPR until help arrives. No matter the state of the pads, the HSl/OnSite/Home AED voice prompts will audibly guide users through each step of the procedure.

Q:     How do I replace pads cartridges on the HSl, OnSite, and Home AEDs?

A:   Locate the latch at the top edge of the AED and slide it to the side. The SMART pads cartridge will be released. Lift out the used SMART pads cartridge. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. A short video showing how to replace the pads cartridge can be found at: www.philips.com/replace-aed-pads­ video

Q:     Is Philips fulfilling orders for MS071A and MS072A pads cartridges?

A:   Yes, Philips continues to fulfill orders for M5071A and M5072A pads cartridges.

Q:    Why have I experienced extended lead times for fulfillment of MS071A and MS072A pads cartridges?

A:   Due to broad-based disruptions in the global supply chain, Philips is currently experiencing extended lead times for product shipments for our Automated External Defibrillator {AED) product categories, including the M5071A and M5072A. The issue described in the Medical Device Correction/Field Safety Notice has not been a contributing factor in pads fulfillment timelines.

Q:     Are new orders being fulfilled with pads that could experience this issue?

A:   Philips shipments of new pads could still experience the issue described in the Medical Device Correction/Field Service Notice. It is not possible to know which pads could experience the problem prior to patient use because the pads are protected by a foil seal. Philips is working on design changes intended to eliminate the issue in the M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval.

Q:   Could M5071A and M5072A pads I received from orders recently fulfilled by Philips experience this issue?

A:     Yes. All Lots of Adult and Infant/Child Pads Cartridges {PNs: M5071A and M5072A) installed in or stored as spares with the HSl, OnSite, and Home AEDs could experience this issue. The Medical Device Correction/Field Service Notice takes into consideration only pads that are unexpired. Philips is working on design changes intended to eliminate the issue in the M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval.

Q:     Why is Philips continuing to fulfill orders with pads that could experience this issue?

A:   The M5071A {Adult) and M5072A {Infant/Child) pads are single-use medical devices marked with an expiration date. Philips believes that the risk to patient safety of using pads that may experience this issue is lower than using expired pads or having no AED available. Therefore, until updated pads are available, Philips plans to continue fulfilling orders so that customers can replace used or expired pads. Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval.

Q:     Will new orders M5071A and MS072A be fulfilled with pads that could experience this issue?

A:   Philips shipments of new pads could still experience the issue described in the Medical Device Correction/Field Service Notice. Philips is working on design changes intended to eliminate the issue in the M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval.

Q:     Is Philips fulfilling orders for AEDs?

A:   Philips continues to fulfill orders for the FRx AED, however, Philips is not fulfilling orders for HSl/OnSite/Home AEDs so as not to increase the number of AEDs in use that depend on M5071A and M5072A pads.

Q:   Does this issue affect the Philips FRx AED?

A:   No, the issue described in the Medical Device Correction/Field Service Notice does not affect the FRx device and pads. Philips continues to fulfill orders for the FRx AED and accessories including SMART Pads II.

Q:    Is Philips fulfilling orders for the FRx AED?

A:   Yes, Philips continues to fulfill orders for the FRx AED.

Q:    Does this issue affect Philips HSl/OnSite/Home AEDs?

A:   The issue described in the Medical Device Correction/Field Service Notice concerns the M5071A and M5072A pads only; it does not concern the HSl/OnSite/Home AED devices. There is no concern with HSl/OnSite/Home AED devices themselves.

Q:     Why is Philips continuing to fulfill orders for HSl/OnSite/Home pads, but not HSl/OnSite/Home devices?

A:   The M5071A {Adult) and M5072A (Infant/Child) pads are single-use medical devices marked with an expiration date. Philips believes that the risk to patient safety of using pads that may experience this issue is lower than using expired pads or having no AED available. Therefore, until updated pads are available, Philips plans to continue fulfilling M5071A and M5072A orders so that customers can replace used or expired pads. However, so as not to increase the number of AEDs in use that depend on M5071A and M5072A pads, Philips has stopped fulfillment of new HSl/OnSite/Home AEDs. 

Q:   When will HSl/OnSite/Home AEDs resume shipping?

A:     Philips is working on design changes intended to eliminate the issue in the MS071A and MS072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval. Philips plans to resume shipments of HSl/OnSite/Home AEDs around the time that updated pads are available.

Q:     Should I remove from service my HSl/OnSite/Home AED due to this issue?

A:   No. Your HSl/OnSite/Home AED should remain in service. Philips believes that the risk to patient safety of using pads that may experience this issue is lower than having no AED available. Users should continue to use the HSl/OnSite/Home AED and pads as-is, and follow the device’s voice prompts during use, because the AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HSl/OnSite/Home AED in service according to the Instructions for Use/Owner’s Manual and the field safety notice.

Q:     What changes to the pads design and production does Philips plan?

A:   Philips is working on changes intended to eliminate the issue in the M5071A and M5072A pads, including updates to production processes and changes to the pad composition.

Q:     Will Philips replace my pads?

A:   Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval. When updated pads are available, Philips plans to supply, free-of-charge, one M5071A (Adult) pad for every HSl/OnSite/Home AED shipped in the preceding 10 years. Philips also plans to supply, free of charge, one M5072A (Infant/Child) pad for every unexpired M5072A recently shipped.

Q:     Why does Philips plan to supply, free of charge, one Adult pad for every HSl/OnSite/Home AED shipped in the preceding 10 years?

A:   Philips’ goal is to eliminate the patient risk associated with this issue. Updated pads are expected to eliminate this issue. Therefore, Philips plans to supply, free­ of charge, one updated M5071A per device to ensure that every HSl/OnSite/Home AED that is st I ll within its 10-year service life will have an updated Adult pads cartridge.

Q:     How and when will I receive an updated M5071A Adult SMART Pads Cartridge?

A:   Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval.

Q:     How and when will I receive an updated M5072A Infant/Child SMART Pads Cartridge?

Philips is working on changes intended to eliminate the issue in M5071A and MS072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval.

Q:     The Medical Device Correction/Field Safety Notice letter states that Philips plans to supply updated pads. Can you be more specific?

A:   When updated pads are available, the free-of-charge pads referenced in the Medical Device Correction/Field Safety Notice letter are planned to include: {a} One free-of-charge M5071A Adult SMART Pads Cartridge for every HSl/OnSite/Home AED shipped in the preceding 10 years, and {b) One free-of­ charge M5072A Infant/Child SMART Pads Cartridge for every unexpired M5072A recently shipped.

Q:     Will Philips supply any new labeling instructions regarding this issue to be put onto the HSl/OnSite/Home AED or inside its carry case?

A:   No matter the state of the pads, the HSl/OnSite/Home AED voice prompts will audibly guide the user through each step of the procedure; therefore, Philips is not planning to supply any new labeling instructions to be put on the device or inside its carry case. Philips recommends, however, that a copy of the Medical Device Correction/Field Safety Notice letter should be kept with the Instructions for Use/Owner’s Manual of your HSl/OnSite/Home AED.

Q:     When updated pads are available, will the M5071A and M5072A pads cartridge part numbers change?

A:   No, there are no plans to change the M5071A and M5072A part numbers.

Q:     When updated pads are available, how can I identify them?

A:   Updated pads are expected to be available later in 2022. When available, updated pads will be identified by their Lot number.

Q:    What can cause gel to separate from the tin/foam liner?

A:   There are many factors that could cause gel to separate from the tin/foam liner.

Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval. 

Q:   Have customers who possess affected pads been notified?

A:   Owners on file of for each HSl/OnSite/Home AED shipped in the past 10 years are being notified per appropriate country regulations.

Q: Why is Philips sending this Medical Device Correction/Field Service Notice letter now?

A:  Philips monitors the performance of medical products used by customers worldwide. At the time of the issuance of the February 2022 notification, Philips has received 115 reports about this issue since 2010 for a total of approximately 5 million shipments of M5071A and M5072A pads, of which 84 were reported within the past year. Due to the increased number of reports recently, Philips is taking action to inform customers about this issue.

Q:   Could this issue pose a risk to the user?

A:   No, Philips has not identified any risk to users due to this issue. 

Q: What should customers do if they have M5071A and M5072A pads affected by this correction?

A: Customers who received the Medical Device Correction notice should read and understand the instructions provided in the letter, fill out and return the Reply Form.

Q:    What should I do if I have an HSl/OnSite/Home AED but have not heard from Philips or a distributor?

A:   Owners of the HSl/OnSite Home AED who have not received a letter from Philips or a distributor by the end of March 2022 may contact Philips or their local Philips Representative. In the USA, customers may call Philips at (800) 263-3342.

Q:     What should I do if I am aware of an impacted Philips device in my facility, but I am not the original purchaser?

A:   Philips or a Philips Distributor will send a letter to the customer of record. Please make a note of the Serial Number(s) of your HSl/OnSite/Home AED(s) and contact Philips. In the USA, customers may call Philips at (800) 263-3342.

Q:     What should I do if I have permanently taken my HSl/OnSite/Home AED out of service?

A:   If you have taken permanently taken your HSl/OnSite/Home AED out of service, please make a note of the Serial Number(s) of the HSl/OnSite/Home AED(s) that were taken out of service if available, and contact Philips. In the USA, customers may call Philips at (800) 263-3342.

Q:   What should I do if I have transferred ownership of my HSl/OnSite/Home AED?

A:   Please provide a copy of the Medical Device Correction/Field Safety Notice letter with the new owner. 

Q:     Who can I contact if I have questions?

A:   Customers may contact their local Philips Representative as shown in the Medical Device Correction letter. In the USA, customers may call Philips at (800) 263-3342.

Philips Recall 2018

February 2018

On February 16, 2018, Philips Healthcare issued a recall notification after discovering certain Philips Heartstart AED(s) (automated external defibrillator(s) in their portfolio has an electrical component (a resistor) that was prone to failure. The affected device list is the Philips HeartStart FRx, Philips Heartstart OnSite, and Philips Home AEDs produced between 2002 and 2013 were recalled as a result of this problem.

Reason for this AED Recall Notification

Ventricular fibrillation (VF), a typical cause of sudden cardiac arrest (SCA), and certain ventricular tachyarrhythmias are all treated with Philips AEDs. The failure rate for Philips AEDs is less than 0.5% per year. Working closely with the FDA, Philips made a voluntary recall for the affected devices.

Reason for this AED Recall Notification

Philips AEDs include automated self-tests that run even when the device is not in use. Tests are done every day, weekly, and monthly. Over 99% of critical performance problems have been identified using these self-tests, which have resulted in audible chirps informing customers. However, isolated failures can occur throughout treatment that is not detected by these self-checks and do so during usage, placing patients at risk of receiving substandard therapy for their VF or VT, which may result in serious injury or even death.

Philips has discovered a problem with one of the electric components (a resistor) in approximately 660,000 AEDs produced between 2002 and 2013. The majority of these resistor-related failures were discovered through automated self-testing, which produces audible chirps as a warning. When an AED determines that a cardiac arrest victim requires shock therapy, the in-use dependability of these AEDs is more than 99.9%.

Self-tests, on the other hand, may not always reveal an issue and the device may not provide a shock when required in rare cases. Philips is aware of 13 occurrences in which this component broke down during treatment, out of more than 45,000 treatments administered. In all of these situations, the gadget gave at least one jolt before failing. Of the patients for whom a patient outcome was recorded, 5 individuals died and 2 were successfully resuscitated and survived.

Understanding Audible Chirps from Your AED

Philips AEDs check themselves on a regular basis to make sure they’re ready to go. Single or triple chirps are sounded if problems are detected during self-checks. The AED will continue to chirp if an error is found, and the device will vibrate until the problem is resolved.

Understanding Audible Chirps from Your AED

Specific Products Covered by This Notification

Philips AED Models: The HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs made from September 2002 through February 2013 are included within the notification because they may have the same type of resistor that has previously caused the failure. The second and third characters in the serial number on the back of the AED indicate the year of manufacture:

Home/Onsite:    A02I-xxxxx through A13B-xxxxx

FRx: B04L-xxxxx through B13B-xxxxx

If your AED was produced in 2013 and the fourth digit in its serial number is the letter “C” or later (D, E, F…), it is not covered by this recall. Because AI3G-02375 does not include the resistor mentioned in this recall warning, it is not a part of this recall.

Specific Products Covered by This Notification

The date of production is 2007, and the stamped number on the device’s casing is A07C-01002. It falls within this alert period and is therefore covered by it.

Serial number Al3C-00773 was manufactured after February 2013. It does not fall within this range and is not covered by this notification because it does not contain the resistor associated with this recall notification.

In September 2012, Philips began informing customers about this risk and providing some helpful instructional videos: www.philips.com/aedaudiblechirps

Importance of FDA Recalls

Recalls are an important safety measure that companies rely on to keep the public informed about risks that may exist in their products. FDA recalls are issued when a company has enough evidence to suggest that its product is defective or dangerous and needs to be fixed by the manufacturer, who then must compensate for any harm caused by its faulty design or production process.

Importance of FDA Recalls

How to Monitor for Recalls

At AED USA our AED management software manages any recall notifications with devices you own. Registering all your AEDs in our portal is extremely important so we can monitor any warranty or recall issues for every device in your AED program.

Cardiac arrest, also known as Sudden Cardiac Arrest (SCA) is a major healthcare problem. It’s also a condition that many people misunderstand. Heart attacks are often mistaken with SCA, which may result in a lack of awareness of its devastating effect on people of all ages.

How to Monitor for Recalls

SCA’s prevalence and lethality are staggering and can be very eye-opening, particularly for those just learning the issue. For example, did you know that:

Every year, 475,000 people die from cardiac arrest in the United States.

Nearly 90% of out-of-hospital cardiac arrests are fatal.

SCA can happen to people of all ages, including children and teens, and even people who appear to be in good health.

Globally, cardiac arrest claims more lives than colorectal cancer, breast cancer, prostate cancer, influenza, pneumonia, auto accidents, HIV, firearms, and house fires – combined!

When a person falls into SCA, the two most common arrhythmias are ventricular fibrillation and ventricular tachycardia. Each of these rhythms is “shockable” with an AED unit.

AEDMD Plus Management Program

Contact us to answer questions and get your AED program on track and compliant. Don’t forget that each state has its own AED laws which make compliance with multi-state AED programs very difficult. Our AEDMD Plus program handles all the compliance for you. Rest easy knowing that your AED is ready and compliant to save a life.

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