A recall from Philips Healthcare for the HeartStart MRx Monitor/Defibrillator has been issued due to safety concerns. The company is recalling the units due to electrical and battery connection issues which could prevent the device from powering up, charging and delivering electrical shock therapy, and could stop corrective pacing. The FDA said that a delay in delivery such therapy could result in serious patient injury. The FDA has determined the cause to be from the device design.
This is for automated external defibrillators (non wearable) – product code MKJ. Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9.
Philips Healthcare is providing Instructions for Use (IFU) an Addendum titled, HeartStart MRx Battery Connector Pins for all customers with affected units. They are 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. Consumers are to 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.
Philips Healthcare is also 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.
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