BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2853244 · Received March 18, 2009

    Report

    Report Number
    1218950-2009-00464
    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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED GETTING A PACING FAILURE WHICH COULD PREVENT THE DELIVERY OF THERAPY. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A PACING FAILURE WHICH COULD PREVENT THE DELIVERY OF THERAPY.

    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