BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTME MODEL 100

    MDR report key: 2881779 · Received November 7, 2012

    Report

    Report Number
    3003793491-2012-00259
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF "BATTERY CAPACITY GAUGE SHOWS A BLANK BATTERY FOR MULTIPLE KNOWN GOOD BATTERIES" WAS NOT CONFIRMED. THE BOARD WAS TESTED WITH FIVE BATTERIES, NO EMPTY BATTERY GAUGE OR LOW BATTERY WARNINGS FOR ANY OF THE BATTERIES WERE GENERATED. ARCHIVE FILE INDICATES THAT THE BATTERIES WERE 3 YEARS OLD, ONE BATTERY (SERIAL # (B)(4)) IS 5 YEARS OLD. FURTHERMORE, ALL BATTERIES INDICATE THAT THEY HAVE HAD LESS TEST CYCLES THAN THEY SHOULD HAVE. THEREFORE, THE PROBABLE CAUSE FOR THE REPORTED EVENT IS THAT THE BATTERIES USED WERE OLD AND/OR NOT PROPERLY MAINTAINED. CUSTOMER DID NOT RETURN ANY BATTERIES FOR EVAL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT UPON PT CARE, THE BATTERY CAPACITY GAUGE SHOWS A BLANK BATTERY FOR MULTIPLE KNOWN GOOD BATTERIES THAT WERE PUT IN THE BOARD AND THE BOARD WOULD NOT RUN. THIS PROBLEM DID NOT NEGATIVELY AFFECT THE PT, USER REVERTED TO MANUAL CPR. THE SAME BATTERIES FUNCTIONED NORMALLY WITH ANOTHER BOARD. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTME MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other