News | February 12, 2018

Philips Recalls HeartStart MRx Defibrillator, Defect May Cause Device Failure

Philips Recalls HeartStart MRx Defibrillator for Defect that May Cause Device Failure.

February 12, 2018 — Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT) that may prevent the device from working automated external defibrillator (AED) mode, or produce noisy ECGs in manual mode. The U.S. Food and Drug Administration (FDA) last week announced it identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death.

Philips said the GDT has micro cracks, which allow internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode. 

As a result of this GDT defect, the HeartStart MRx may fail at any time, including when delivering repeated shocks in AED mode, or during the periodic Operational Check outlined in the device's Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy. Continued use of the device in AED mode after failure may lead to serious patient injury or death.

However, the FDA said the HeartStart MRx will continue to work in manual mode after AED mode failure, though the electrocardiogram (ECG) displayed on the device will be noisy, which may make provider interpretation difficult.

On June 13, 2017, Philips issued a Medical Device Correction Notification letter informing customers of the device's risks.The letter directed customers to:
   • Check all inventory for affected models of the HeartStart MRx Defibrillator.
   • Contact Philips if the HeartStart MRx Defibrillator fails to function as intended. If the device fails to function, users:
   • Should switch the device to manual mode (if previously operating in AED mode).
   • May still use the ECG display and waveforms from other monitoring leads to identify a shockable rhythm and deliver shock therapy while in manual mode.
   • May notice the device indicates poor pad placement even though the pads are appropriately positioned.
   • Will be contacted by Philips to repair the affected device(s) once replacement parts are available.

Customers who have questions or need additional information or support regarding this recall should contact their local Philips representative.

The recall is for model numbers M3535A, M3536A. The manufacturing dates are between Sept. 22, 2016 to Oct. 31, 2016, and they were distributed between Sept. 26 to Nov. 2, 2016. The recall includes 71 devices in the United States.

For more information from the FDA.

Read about an earlier HeartStart MRx recall in March 2017 regarding electrical and battery connection issues.

 

Related Content

Bystanders using a Philips HeartStart AED for a patient in sudden cardiac arrest.

Bystanders using a Philips HeartStart AED for a patient in sudden cardiac arrest.

News | Defibrillator Monitors | June 23, 2020
June 23, 2020 — Philips announced the U.S.
The U.S. Food and Drug Administration (FDA) has lifted its injunction prohibiting the manufacturing and shipping of external defibrillator AEDs in the United States. 
News | Defibrillator Monitors | April 24, 2020
April 24, 2020 — The U.S.
tryker is launching a voluntary field action on specific units of the LifePAK 15 defibrillator/monitors. The vendor said an issue has been identified where the devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.

tryker is launching a voluntary field action on specific units of the LifePAK 15 defibrillator/monitors. The vendor said an issue has been identified where the devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.

News | Defibrillator Monitors | January 13, 2020
January 13, 2020 — Stryker announced it is launching a voluntary field action on specific units of the LifePAK 15 ...
Philips Receives FDA PMA for HeartStart OnSite and HeartStart Home Defibrillators

The Philips HeartStart OnSite automated external defibrillator. Image courtesy of Philips Healthcare.

Technology | Defibrillator Monitors | June 19, 2019
Philips announced the U.S. Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA)...
HeartHero Personal Automated External Defibrillator Wins ACC.19 Innovation Challenge
News | Defibrillator Monitors | April 05, 2019
April 5, 2019 — Medical device startup HeartHero was the winner in the Innovation Challenge at the...
Stryker has recalled its LifePak 15 defibrillator-monitor system because it may lock up after delivering a shock to a patient. The defibrillator was originally made by Physio-Control, before being purchased by Stryker.

Stryker has initiated a field action to prevent its LifePak 15 defibrillator-monitor systems from locking up after delivering a shock to a patient. 

Feature | Defibrillator Monitors | February 04, 2019
February 4, 2019 — Stryker announced Feb.
The Zoll LifeVest wearable defibrillator was the subject of the VEST Trial

The Zoll LifeVest wearable defibrillator system was evaluated in the late-breaking VEST Trial presented at ACC 2018 earlier this year.

Feature | Defibrillator Monitors | July 10, 2018 | Michael J. Mirro, M.D.
Following the...
Rice University Students Improve AED Operation With Needle Pad

The automated external defibrillator add-on developed by Rice University students is a pad of needles that break through the skin's natural impedance barrier to deliver an electric shock to the heart of a patient in cardiac arrest. (Credit: Jeff Fitlow/Rice University)

News | Defibrillator Monitors | April 16, 2018
The skin presents a formidable barrier to life-saving defibrillators, but a team of students from Rice University...
Zoll Canada Equipping Province of Québec Paramedic Services with X Series Monitor/Defibrillators
News | Defibrillator Monitors | October 16, 2017
October 16, 2017 — Zoll Canada, a subsidiary of Zoll Medical Corp., announced it has won the tender to equip all ambu