BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2023105 · Received February 15, 2011

    Report

    Report Number
    1218950-2011-00407
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE IS NOT DETECTING THE PADS CABLE/TEST LOAD. THE UNIT WAS EVALUATED BY A PHILIPS REP. REPLACING THE THERAPY PCA RESOLVED THE REPORTED ISSUE. THE UNIT WAS TESTED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE IS NOT DETECTING THE PADS CABLE/TEST.

    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