BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3772381 · Received February 28, 2014

    Report

    Report Number
    3772381
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 14, 2014
    Report Date
    February 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHILE PATIENT WAS ON CARDIO-PULMONARY BYPASS UNDERGOING A REPAIR OF SUBPULMONARY OBSTRUCTION, THE INTERNAL PADDLES CONNECTED TO THE DEFIBRILLATOR FAILED TO DISCHARGE. ANOTHER DEFIBRILLATOR AND INTERNAL PADDLES WERE OBTAINED WITHOUT DELAY AND THE INTERNAL PADDLES SUCCESSFULLY CHARGED AND DISCHARGED. MD WAS PRESENT. DEFIBRILLATOR AND INTERNAL PADDLES WERE SENT TO BIOMEDICAL ENGINEERING FOR ANALYSIS. WHEN ANALYZED BY BIOMEDICAL, THE DEFIBRILLATOR WORKED WHEN THE DEFIBRILLATOR ANALYZER WAS CONNECTED BUT THE INTERNAL PADDLES WERE FOUND TO BE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125065 * AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4742A *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR