BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 809424 · Received July 13, 2006

    Report

    Report Number
    9610483-2006-00149
    Event Type
    Other
    Date Received
    July 13, 2006
    Date of Event
    October 17, 1999
    Report Date
    November 4, 1999
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    MKJ
    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 PROPER OPERATION FOR PATIENT TREATMENT WAS VERIFIED. THE 2 RETURNED NON-LAERDAL BATTERIES, BOTH EXPIRED LOT 950412, WERE TESTED TO FIND THAT NEITHER HAD THE CAPACITY FOR EVEN ONE SHOCK BEFORE IT SHUT THE DEFIBRILLATOR DOWN PROMPTING "REPLACE BATTERY, BATTERY LOW." THE MESSAGE "REPLACE BATTERY, BATTERY LOW" PROMPTS WHEN THE BATTERY LACKS THE CAPACITY TO PREFORM AS REQUIRED AND THE DEFIBRILLATOR SHUTS DOWN. THE HS3000 OPERATING INSTRUCTIONS EXPLAIN BATTERY LIFE AND MAINTENANCE, INCLUDING RECOMMENDED USE OF LAERDAL BATTERIES ONLY, A DEFINED PERIODIC BATTERY CAPACITY TEST AND REPLACEMENT OF BATTERIES AFTER 2 YEARS. RPTR WAS SENT A LETTER EXPLAINING OUR EVALUATION. THIS REPORT IS THE RESULT OF A RETROSPECTIVE COMPLAINT REVIEW BY LMC. IT IS TIMELY FILED UNDER LMC'S REVISED MDR PROCEDURE AND ITS WRITTEN COMMITMENT TO THE AGENCY, EACH OF WHICH HAS RESULTED FROM LAERDAL'S RECEIVING INFORMATION RELATING THE AGENCY'S CURRENT THINKING WITH RESPECT TO MDR REGULATION INTERPRETATION AND ENFORCEMENT POLICY.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 1999 INVOLVING A MALE PATIENT IN CARDIAC ARREST WITH BYSTANDER CPR IN PROGRESS FOR AT LEAST 4 MINUTES, THIS DEFIBRILLATOR STARTED TO CHARGE, THEN PROMPTED "LOW BATTERY, CHANGE BATTERY" AND TURNED OFF. A SECOND BATTERY WAS INSTALLED AND THE SAME THING HAPPENED. ALS ARRIVED AND ASSUMED ALS PATIENT CARE. THE PATIENT WAS SHOCKED AT 200J (12:59), PEA @ 40 (13:05) AND ASYSTOLE (13:11). THE PATIENT WAS TRANSPORTED TO A HOSPITAL. THE PATIENT'S BROTHER SAID HE WAS "NOT FEELING WELL" AND WHILE WALKING THIS AM, "GRABBED CHEST AND COLLAPSED." THE BROTHER STARTED CPR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL, A.S. HS3000 9312

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other