Class 1 Recall: Philips Electronics Recalls HeartStart MRx Defibrillator Due to Defects in Gas Discharge Tubes Which May Cause Device Failure
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Mon Feb 12 2018
Recalled Product(s):
- Philips Electronics North America Corporation, HeartStart MRx Defibrillator
- Model/Item Numbers: M3535A, M3536A
- Lot Numbers: See "Full List of Affected Devices"
- Manufacturing Dates: September 22, 2016 to October 31, 2016
- Distribution Dates: September 26, 2016 to November 2, 2016
- Devices Recalled in the U.S.: 71
Device Use
The Philips HeartStart MRx Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down.
The HeartStart MRx Monitor/Defibrillator is intended for use by or on the order of a physician, and should only be administered by medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.
Image of the Philips HeartStart MRx Defibrillator
Reason for Recall
Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows 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 HeartStart MRx will continue to work in "Manual" mode after AED mode failure, though the electrocardiogram (EKG) displayed on the device will be noisy, which may make provider interpretation difficult.
Who May be Affected
- Health care providers and first responders using a Philips HeartStart MRx Defibrillator manufactured between September 22, 2016 and October 31, 2016.
- Patients who may need defibrillation or pacing to restore normal heart rhythm.
What to Do
On June 13, 2017, Philips Electronics sent affected customers a "Medical Device Correction Notification" informing them of the device's risks. In the letter, Philips directed customers to:
- Check all inventory for affected models of the HeartStart MRx Defibrillator.
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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 EKG 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.
Contact Information
Customers who have questions or need additional information or support regarding this recall should contact their local Philips representative.
Date Recall Initiated
June 13, 2017
Full List of Affected Devices
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.