BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1926390 · Received November 11, 2010

    Report

    Report Number
    1218950-2010-02242
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    October 14, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED TO PHILIPS THAT ONE OF THE BATTERY PCA PINS WAS BROKEN AND MISSING AND THE UNIT FAILED TO POWER UP. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE AND VERIFIED THE FAILURE. REPLACEMENT OF THE BATTERY PCA RESOLVED THE FAILURE. THE UNIT PASSED ALL POST SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT ONE OF THE BATTERY PCA PINS WAS BROKEN AND MISSING AND THE UNIT FAILED TO POWER UP.

    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