BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2971911 · Received January 18, 2013

    Report

    Report Number
    3003793491-2013-00119
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 17, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF THE PLATFORM PERFORMED COMPRESSIONS FOR A SHORT TIME AND POWERED OFF WAS CONFIRMED. SERVICE WAS ABLE TO REPLICATE THE SUDDEN SHUTDOWN WHEN RUNNING THE DEVICE WITH LRTF (LARGE RESUSCITATION TEST FIXTURE), WHICH IS EQUAL TO A 250 POUND PT. SERVICE DISCOVERED THAT THE POWER DISTRIBUTION BOARD (PDB) WAS DEFECTIVE. PLATFORM PASSED THE RUN_IN TEST WITH A KNOWN GOOD PDB. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATFORM PERFORMED COMPRESSIONS FOR ABOUT A MINUTE OR TWO AND POWERED OFF. THE BATTERY WAS CHANGED, BUT THE PLATFORM POWERED OFF AFTER A FEW COMPRESSIONS AGAIN. THE CREW RESUMED MANUAL COMPRESSIONS. CUSTOMER INDICATED THAT THEY PERFORMED THE MORNING BATTERY CHANGE OUT AND DAILY CHECK AND THAT THERE WERE NO KNOWN BATTERY ISSUES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28768 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1