BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PAK 500

    MDR report key: 4317284 · Received December 4, 2014

    Report

    Report Number
    MW5039424
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 4, 2014
    Manufacturer
    PHYSIO CONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LP500 AED USED FOR A PT IN CARDIAC ARREST. PADS WERE PROPERLY PLACED ON PT WITH GOOD ADHESION TO CHEST. DURING THE "ANALYZE" PHASE, MACHINE INDICATING "MOTION DETECTED" DESPITE NO ONE TOUCHING OR MOVING THE PT. THIS CONTINUED TO OCCUR 3 TIMES DESPITE ALL EFFORTS TO TROUBLESHOOT THE MACHINE. THIS AED WAS DISCONTINUED AND ANOTHER AED WAS USED FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784701 LIFE PAK 500 AED MKJ PHYSIO CONTROL LIFE PAK 500

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR PACING/DEFIBRILLATION/ECG ELECTRODES (ADULT)| PHYSIO-CONTROL QUIK-COMBO