BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3170945 · Received June 6, 2013

    Report

    Report Number
    1218950-2013-02126
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 STATED THAT AFTER COMPLETING THE OPERATIONAL CHECK, THE PRINTER WOULD NOT STOP PRINTING; THE BUTTONS WERE FROZEN AND THEY HAD TO PULL THE POWER AND BATTERY TO TURN OFF DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251818 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1