BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3170608 · Received May 28, 2013

    Report

    Report Number
    1218950-2013-02002
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Report Date
    April 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE OPERATIONAL CHECK. THE SERIAL NUMBER OF THE DEVICE IS NOT YET KNOWN. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233158 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1