BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1811461 · Received August 17, 2010

    Report

    Report Number
    1218950-2010-01330
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Report Date
    July 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT WOULD SHUT DOWN WHEN ON THE B COMPARTMENT BATTERY. 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

    THE CUSTOMER REPORTED THAT THE UNIT WOULD SHUT DOWN WHEN ON THE B COMPARTMENT BATTERY.

    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