The FDA has classified the recall of over 47,000 Philips HeartStart MRx Monitor/Defibrillators as a Class I recall.
According to the FDA, Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice on 2/24/17. The Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.
Action (1) Philips is voluntarily initiating this correction and is providing Instructions for Use (IFU) Addendum titled, HeartStart MRx Battery Connector Pins for all customers with affected units. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Philips is asking the customer when inspecting the device, to inspect the HeartStart MRx battery compartment connections. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue.
Action (2) Philips is voluntarily initiating this correction and is providing measures to prevent, or methods to allow the user to correct, the abnormal device behavior related to charging and pacing after disconnecting the device from AC mains.
Battery and electrical connection issues in the device (HeartStart MRx Monitor/Defibrillator), used to pace patients with bradycardia or shock patients with sudden cardiac arrest, may prohibit it from charging, powering up and delivering electrical shock therapy, according to a MedWatch report from the FDA.
The agency wrote that the device may also stop pacing, and its use may result in serious injuries such as permanent organ damage and brain injury or death.
