BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2853259 · Received March 18, 2009

    Report

    Report Number
    1218950-2009-00463
    Event Type
    Malfunction
    Date Received
    March 18, 2009
    Report Date
    March 18, 2009
    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

    THE CUSTOMER REPORTED THAT THE UNIT WAS FAILING THE PADS/PADDLES ECG TEST. THE DEVICE WAS EVALUATED AT PHILIPS, AND THE FAILURE WAS CONFIRMED. REPLACING THE POWER PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS FAILING THE PADS/PADDLES ECG TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1