Federal health officials have announced a Class I medical device recall for certain defibrillators, due to a risk that they may fail to provide necessary shock therapy in the event of a cardiac event, potentially resulting in serious injury or death.
A Philips HeartStart MRx defibrillator recall was announced by the FDA on February 9, due to a risk that the device’s Gas Discharge Tube (GDT) may contain micro cracks, which could allow gases to escape and result in a shock treatment failure.
The recalled defibrillators are intended for use by physicians or trained medical personnel, to deliver electrical current shocks to individuals with irregular heartbeats, and in emergency circumstances when heart rates decline or stop.
The FDA has issued a recall for the devices due to the potential for the GDT to possess micro cracks which can allow gasses to escape and cause the tubes to not function as expected. The defect may also allow an electrical current surge to cross the device’s designated resistors, potentially damaging the resistors and preventing the device from working while in automated external defibrillator (AED) mode.
The recall involves HeartStart MRx defibrillators marked with model numbers M3536A and M3536A that were manufactured by Philips Electronics from September 22, 2016 through October 31, 2016, and were distributed throughout the United States to licensed healthcare professionals from September 26, 2016 through November 2, 2016.
Philips Electronics sent a Medical Device Correction Notification on June 13, 2017 to all known consumers to check their inventory and to contact the manufacturer if the HeartStart MRx defibrillators fail to function properly.
However, due to the severity and potentially fatal outcome as a result of a device failure, the FDA issued a Class I recall for the devices, indicating the use of the device could result in serious and potentially fatal outcomes.
Customers will be receiving the recall correspondence from Philips Electronics with instructions. FDA officials are encouraging customers to report any adverse health events to their MedWatch Safety Information and Adverse Event Reporting Program at 1-800-332-1088.