BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 808823 · Received June 14, 2006

    Report

    Report Number
    9610483-2006-00109
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    September 8, 2000
    Report Date
    September 11, 2000
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY ASSOCIATED WITH THIS COMPLAINT, LOT 990118, WAS NOT RETURNED FOR THIS EVALUATION. THE UNIT AT THE SCENE WAS RETURNED TO LAERDAL AT A LATER DATE AND WAS FOUND TO BE OPERATING PROPERLY FOR PT TREATMENT. THERE HAS BEEN NO TREND OF BATTERY PROBLEMS INVOLVING THIS BATTERY LOT # 990118. THERE IS NO RECORD OF THE NUMBER OF HRS THE CUSTOMER CHARGED THIS BATTERY BEFORE THEIR TEST THAT RESULTED IN 3 SHOCKS BEFORE THE "LOW BATTERY" CONDITION. THE CUSTOMER'S STATEMENT WAS "CHARGED ALL NIGHT". THE HS3000 OPERATING INSTRUCTIONS STATE THAT A LAERDAL BATTERY WILL REACH FULL CAPACITY WITHIN 16 HRS OF CHARGING AND REQUIRES THE BATTERY HAVE THE CAPACITY FOR 15 360J SHOCKS TO BE ACCEPTABLE FOR PT TREATMENT. THE MESSAGE "BATTERY LOW" IS DISPLAYED WHEN THE REMAINING BATTERY CAPACITY IS SUFFICIENT FOR 2-3 SHOCKS ONLY. "REPLACE BATTERY, BATTERY LOW" IS DISPLAYED WHEN BATTERY CAPACITY IS TOO LOW TO GUARANTEE OPERATION OF THE UNIT AND OPERATION IS DISABLED (THE UNIT SHUTS DOWN).

    Description of Event or Problem · 1

    DURING AN INCIDENT ON 9/8/00 INVOLVING A MALE PT IN CARDIAC ARREST, THIS DEFIBRILLATOR SHOCKED 3 TIMES AND THEN PROMPTED "LOW BATTERY", SHOCKED AND THEN THE SCREEN WENT BLANK. THE PT WAS TRANSPORTED TO A HOSP AND HAD A PULSE IN THE AMBULANCE AND UPON ARRIVAL AT THE HOSP. THE BATTERY EXPIRATION DATE WAS 7/2001. IT WAS CHARGED ALL NIGHT AND WHEN USED THE NEXT DAY WITH A SIMULATOR, DELIVERED 3 SHOCKS BEFORE PROMPTING "LOW BATTERY". THE CUSTOMER REPORTED THIS EVENT AS A BATTERY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED LDD LAERDAL MEDICAL A.S. HS3000QR 9308

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other