BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1902864 · Received November 12, 2010

    Report

    Report Number
    1218950-2010-02259
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 15, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    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): IT WAS REPORTED THAT THE UNIT FAILED TO RECOGNIZE THE PADS CABLE. THE UNIT WAS EVALUATED AT THE PHILIPS REPAIR BENCH AND THE FAILURE WAS VERIFIED. REPLACING THE POWER PCA RESOLVED THE FAILURE. THE UNIT WAS RETURNED TO THE PHILIPS DEMO POOL AFTER PASSING ALL POST SERVICE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT FAILED TO RECOGNIZE THE PADS CABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1