BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SEMI-AUTOMATED DEFIBRILLATOR

    MDR report key: 11446 · Received February 11, 1994

    Report

    Report Number
    MW1000725
    Event Type
    Malfunction
    Date Received
    February 11, 1994
    Date of Event
    December 24, 1993
    Report Date
    January 13, 1994
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    PT IN CARDIAC ARREST. THE DEVICE SHOCKED ONCE, CHARGED, THEN DUMPED PRIOR TO ORDERING THE SECOND SHOCK, THEN ADVISED "NO SHOCK." AN ANALYSIS ONE MINUTE LATER AGAIN ADVISED A "NO SHOCK." PER THE MEMORY CONTROL MODULE PRINTOUT, THE PT REMAINED IN VENTRICULAR FIBRILLATION THROUGHOUT THE ENTIRE TIME THE DEVICE WAS ON (OF SIMILAR AMPLITUDE). PARAMEDICS ARRIVING ON THE SCENE, SHOCKED THE PT AT 200 W/S AND 300 W/S TO GET HIM OUT OF VENTRICULAR FIBRILLATION. THE PT WAS IN VENTRICULAR FIBRILLATION FROM 10:07 AM TO 10:17 AM. WHEN THE PARAMEDICS AFTER TWO ADD'L SHOCKS CONVERTED HIM TO ASYSTOLE. THE PT WAS PRONOUNCED IN THE HOSP ER. THE DEVICE'S AUDIO/MONITOR RECORDER (TAPE) ALSO DID NOT RECORD THE CALL. THE TAPE RECORDER RECORDED POORLY ON 3 CONSECUTIVE CALLS. THE TAPE RECORDING SYSTEMS ARE THE WEAKEST LINK ON THESE MACHINES. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SEMI-AUTOMATED DEFIBRILLATOR LDD LAERDAL MEDICAL CORP. HS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other