BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 3063430 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01111
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    May 21, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN ERROR, CLINICAL MODE NOT AVAILABLE. THE DEFIBRILLATOR GOES STRAIGHT TO SERVICE MODE AT STARTUP, AND NOT TO DIAGNOSTIC MODE. NOTE THAT THIS IS EXPECTED BEHAVIOR IF THE A CLINICAL FAILURE IS GENERATED DURING THE OPCHECK WHICH CAN RESULT FROM THE TEST BEING RUN IMPROPERLY. ON (B)(4) 2012, THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE ISSUE WAS CLARIFIED AS A PADS ECG FAILURE. THE ISSUE WAS LOCALIZED TO THE THERAPY PCA. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THIS WAS A MALFUNCTION OF THE THERAPY PCA. REPLACEMENT OF THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR, CLINICAL MODE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127352 HEARTSTART XL+ DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1