BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2614753 · Received June 6, 2012

    Report

    Report Number
    MW5025725
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 6, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR KNOB WAS SET TO 200 J, BUT THE DEFIBRILLATOR WENT INTO AED ON MODE. NO PT WAS INJURED IN THIS EQUIPMENT MALFUNCTION. BIOMEDICAL ENGINEERING WENT INTO THE CONTROLS TEST MENU AND VERIFIED THAT WHEN THE KNOB IS SET TO 200 J, IT DISPLAYED "AED ON" NOT 200 J. WHEN THE KNOB WAS SET FOR 7 J, IT DISPLAYED/PRODUCED 30 J. WHEN THE KNOB WAS SET FOR 150 J IT DISPLAYED/PRODUCED 50 J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1