BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSART

    MDR report key: 751397 · Received August 15, 2006

    Report

    Report Number
    9610483-2006-00165
    Event Type
    Other
    Date Received
    August 15, 2006
    Date of Event
    January 23, 1999
    Report Date
    February 2, 1999
    Manufacturer
    LAERDAL MEDICAL A.S
    Product Code
    LDD
    PMA / PMN Number
    K896919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED USING A KNOWN GOOD POWER SOURCE AND DURING SELF-TEST, THE DISPLAY BACKLIGHT FLICKERED AND THE UNIT SHUT DOWN WITH 2 LINES ACROSS THE SCREEN AND WITH 2 BEEPS REPEATING. A SHORT CIRCUIT WAS FOUND ON THE BACKLIGHT DISPLAY CAUSING A CURRENT DRAIN THAT SHUT THE UNIT DOWN WITH 2 BLACK LINES DISPLAYED AND 2 AUDIBLE BEEPS. THE DISPLAY ASSEMBLY WAS REPLACED AND PROPER OPERATION FOR PATIENT TREATMENTS WAS VERIFIED.THE REPORTED COMPLAINT THAT THE UNIT POWERED ON WITH THE MESSAGE "MONITORING ONLY" WAS NOT VERIFIED AND CANNOT BE EXPLAINED. THE ELECTRODE PADS USED AT THE SCENE WERE NOT RETURNED FOR EVALUATION. NO REPORT OF THE UNIT POWERING OFF WAS MADE. THE 2 RETURNED EXPIRED BATTERIES, LAERDAL LOT 961028 AND NON-LAERDAL LOT 930915, WERE BOTH VERIFIED TO LACK THE CAPACITY FOR EVEN ONE SHOCK, SHUTTING THE UNIT DOWN DURING THE SELF-TEST AND FAILING THE BATTERY CAPACITY TEST DEFINED IN THE HS3000 OPERATING INSTRUCTIONS. WE BELIEVE THE POOR PATIENT-TO-ELECTRODE PAD CONTACT, HIGH TRANSTHORACIC PATIENT IMPEDANCE OR A COMBINCATION OF THESE FACTORS PREVENTED THE DEVICE FROM ANALYZING THE PATIENT. POOR ELECTRICALCONTACT CAN BE CAUSED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, THE PATIENT'S SKIN CONDITION AND HAIR, SKIN PREP, INADEQUATE PAD ADHESION, AND ELECTRODE DISCREPANCIES. REP WAS STENT A LETTER, WITH A COPY TO ANOTHER REP, EXPLAINING OUR EVALUATION AND THE CONDITION OF THEIR BATTERIES.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 1999, INVOLVING A FEMALE PATIENT IN CARDIAC ARREST, THIS DEFIBRILLATOR STARTED UP WITH A "MONITOR ONLY" MESSAGE AND WOULD NOT ANALYZE OR DELIVER SHOCKS. THE PADS AND CONNECTIONS WERE CHECKED AND NO PROBLEMS WERE FOUND. CPR WAS STARTED. AN ALS CREW ARRIVED AND TOOK OVER PATIENT CARE. THE PATIENT WAS TRANSPORTED TO A HOSPITAL AND WAS PRONOUNCED DOA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSART SAED LDD LAERDAL MEDICAL A.S HS3000 9411

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other