BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART DEFIBRILLATOR ELECTRODES

    MDR report key: 217282 · Received April 1, 1999

    Report

    Report Number
    1719891-1999-00010
    Event Type
    Death
    Date Received
    April 1, 1999
    Date of Event
    March 1, 1999
    Report Date
    April 1, 1999
    Manufacturer
    CARDIOTRONICS SYSTEMS, INC., DIV OF BALLARD MEDICAL
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3/1/99, HOSPITAL STAFF WITNESSED A 63 YEAR-OLD-FEMALE PATIENT GO INTO CARDIAC ARREST. CPR WAS STARTED. A HEARTSTART 3000 DEFIBRILLATOR WITH ELECTRODE PADS WAS ATTACHED. THIS TYPE OF DEFIBRILLATOR WITH PADDLES WAS AVAILABLE FOR USE ON THE PATIENT. WHEN RESUSCITATION BEGAN, THE DEFIBRILLATOR DISPLAYED A "CHECK ELECTRODES" MESSAGE. WHEN HOSPITAL STAFF CHECKED THE ELECTRODE PADS WERE OPENED AND THEY WERE ALSO WATERY. IT WAS NOT POSSIBLE TO ANALYZE OR SHOCK THE PATIENT SINCE THE ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT. ACCORDING TO THE REPORT ANOTHER DEFIBRILLATOR WAS SUMMONED BUT THE PATIENT HAD DIED. BALLARD MEDICAL PRODUCTS REQUESTED THAT LAERDAL MEDICAL NORWAY RECALL THESE ELECTRODES ON 2/15/99 AND THE RECALL WAS IN PROGRESS AT THE TIME OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART DEFIBRILLATOR ELECTRODES EXTERNAL DEFIBRILLATION ECG MONITORING ELECTRODES DRX CARDIOTRONICS SYSTEMS, INC., DIV OF BALLARD MEDICAL 902400 7/6/99

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death HEARTSTART 3000 DEFIBRILLATOR.