BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL DEFIBRILLATOR

    MDR report key: 3890019 · Received June 2, 2014

    Report

    Report Number
    3890019
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    September 25, 2013
    Report Date
    November 5, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR CHARGED AT 100 JOULES IN SYNCH MODE AND WOULD NOT FIRE. CHARGED AGAIN AT 150 JOULES AND STILL WOULD NOT FIRE. MACHINE AND CORD CONNECTIONS CHECKED, BUT STILL UNABLE TO FIRE. USED A SECOND DEFIBRILLATOR TO FINISH PROCEDURE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322524 HEARTSTART XL DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS MEDICAL SYSTEMS M4735 1205618

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR