BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFBRILLATOR

    MDR report key: 3182455 · Received June 11, 2013

    Report

    Report Number
    1218950-2013-02276
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE HAVING TROUBLE WITH THE EXTERNAL POWER AND THE DEVICE KEEPS TURNING OFF RANDOMLY. CUSTOMER STATES NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264928 HEARTSTART MRX-EMS DEFBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1