BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2072770 · Received March 31, 2011

    Report

    Report Number
    1218950-2011-00858
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Report Date
    March 3, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT FREEZES UP AFTER RUNNING OPCHECK. THERE WAS NO REPORT OF PT INVOLVEMENT. THE PHILIPS FIELD SERVICE ENGINEER REPORTED THAT THE UNIT WOULD REBOOT AND NOT POWER UP IN MONITORING MODE. THE PROCESSOR PCA WAS REPLACED WHICH RESOLVED THE FAILURE. THE UNIT PASSED ALL POST SERVICING TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FREEZES UP AFTER RUNNING OPCHECK. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1