BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2222408 · Received July 15, 2011

    Report

    Report Number
    1218950-2011-02037
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    June 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNIT DOES NOT POWER ON WITH BATTERY IN EITHER BAY. NO REPORTED PATIENT INVOLVEMENT. THIS LOANER UNIT WAS EVALUATED AT THE PHILIPS REPAIR BENCH AND IT WAS FOUND THAT THE UNIT FAILED TO POWER UP ON BATTERY POWER DUE TO BROKEN BATTERY PCA CONNECTION PINS. THERE WAS NO PATIENT INVOLVEMENT. REPLACING THE BATTERY PCA RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    UNIT DOES NOT POWER ON WITH BATTERY IN EITHER BAY. NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1