BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 863534 · Received September 26, 2006

    Report

    Report Number
    9610483-2006-00232
    Event Type
    Other
    Date Received
    September 26, 2006
    Date of Event
    December 19, 2001
    Report Date
    January 3, 2002
    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 PT TREATMENT WAS VERIFIED. USING THE 2 RETURNED BATTERIES, LAERDAL LOT 990310 AND NON-LAERDAL EXPIRED LOT 940210, THE COMPLAINT OF "DID NOT SHOCK" WAS VERIFIED. THE LAERDAL BATTERY SHUT THE UNIT DOWN DURING THE FIRST CHARGE PROMPTING "REPLACE BATTERY, BATTERY LOW". THE NON-LAERDAL BATTERY WAS NOT ABLE TO POWER ON THE UNIT. THE INCIDENT REPORT PRINTED FROM THE RETURNED MCM DOCUMENTS ONE POWER ON, CHARGE AND SHUT DOWN WITH A PROMPT OF "REPLACE BATTERY, BATTERY LOW". THE SECOND BATTERY COULD NOT POWER ON THE UNIT SO THERE WAS NO SECOND POWER-UP DOCUMENTED IN THE EVENT LOG. THE MESSAGE "REPLACE BATTERY, BATTERY LOW" PROMPTS WHEN THE BATTERY LACKS THE CAPACITY TO PERFORM AS REQUIRED AND THE DEFIBRILLATOR SHUTS DOWN. THE HS3000 OPERATING INSTRUCTIONS EXPLAIN THIS PROMPT AND WHAT TO DO SHOULD IT BE EXPERIENCED. REP WAS SENT A LETTER, WITH A COPY TO REP , EXPLAINING THE LIFE AND MAINTENANCE OF THE LAERDAL BATTERY PER THE HS3000 DFU, POINTING OUT THE IMPORTANCE OF PERIODIC BATTERY CAPACITY TESTS AND REPLACEMENT AFTER TWO YEARS.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 2001, INVOLVING A MALE PT WHO WAS UNCONSCIOUS, UNRESPONSIVE, PULSELESS APNEIC AND IN CARDIAC ARREST WITH CPR INITIATED, THIS DEFIBRILLATOR PROMPTED "LOW BATTERY" WHEN ANALYZE WAS PRESSED. THE BATTERY WAS REPLACED AND THE UNIT TURNED ON WITH AN ERROR MAINTENANCE MESSAGE. ANOTHER CREW'S DEFIBRILLATOR WAS USED WITH ONE MINUTE DELAY AND THE PT WAS TRANSPORTED OT A HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL A.S. HS3000 9704

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other