BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3060692 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01128
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE HAD A DISPLAY THAT STOPPED WORKING AFTER BEING ON FOR A FEW MINUTES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND DID NOT CONFIRM THE PROBLEM. THE FSE RAN OPCHECK, VERIFIED ALL PARAMETERS AND DEVICE OUTPUT. NO PROBLEM WAS FOUND. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE AND PARAMETER CHECKS AND OUTPUT SPECIFICATIONS. THE DEVICE WAS PUT BACK INTO USE. AS OF ON 03/27/2013 THERE HAVE BEEN NO FURTHER CALLS FOR THIS DEVICE WITH THIS PROBLEM. SINCE THE PROBLEM COULD NOT BE RECREATED THE CAUSE COULD NOT BE DETERMINED. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAD A DISPLAY THAT STOPPED WORKING AFTER BEING ON FOR A FEW MINUTES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127269 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1