BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 2943419 · Received January 30, 2013

    Report

    Report Number
    1218950-2013-00332
    Event Type
    Death
    Date Received
    January 30, 2013
    Date of Event
    October 16, 2012
    Report Date
    November 1, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION REVEALED THAT A SOFTWARE DEFECT COULD CAUSE THE DEVICE TO LOCK OUT THERAPY MODE IN CERTAIN CIRCUMSTANCES. A SOFTWARE FIX IS BEING DEVELOPED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN "EQUIPMENT DISABLED" MESSAGE DURING CARE OF A PT. THE INVOLVED PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40167 HEARTSTART XL+ DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1 Death