BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2505910 · Received March 6, 2012

    Report

    Report Number
    1218950-2012-00773
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Report Date
    February 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT UNIT TURNED OFF WHILE ON A CALL. THE CUSTOMER ALSO REPORTED THAT THE DEVICE WAS POWER CYCLING. THERE WAS NO NEGATIVE IMPACT TO THE PT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE. THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE PASSED PERFORMANCE TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UNIT TURNED OFF WHILE ON A CALL. THERE WAS NOT NEGATIVE IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1