BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2042938 · Received March 30, 2011

    Report

    Report Number
    1218950-2011-00838
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    March 4, 2011
    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 INCONSISTENT PADS / PADDLES MESSAGES. THERE WAS NO NEGATIVE PT IMPACT REPORTED. PHILIPS EVALUATED THE DEVICE AND VERIFIED THE MALFUNCTION. THE THERAPY CABLE AND THERAPY PORT WERE REPLACED TO RESOLVE THE ISSUE. THIS FAILURE IS CONSISTENT WITH AN INTERMITTENT ELECTRICAL CONNECTION BETWEEN THE THERAPY CABLE AND THE THERAPY PORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCONSISTENT PADS / PADDLES MESSAGES.

    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