BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3173432 · Received June 9, 2013

    Report

    Report Number
    3003793491-2013-00679
    Event Type
    Malfunction
    Date Received
    June 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM S/N (B)(4) WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE FRONT ENCLOSURE AND BATTERY LOCK WERE DAMAGED. NOTE: TWO NIMH BATTERIES WITH UNK LOT NUMBERS WERE REPORTED BY THE CUSTOMER AS BEING ASSOCIATED WITH THIS EVENT. IT SHOULD BE NOTED THAT THREE BATTERIES WITH THE FOLLOWING S/N WERE RETURNED FOR EVALUATION; (B)(4). ARCHIVE DATA REVIEW SHOWED THAT ALL THREE BATTERIES WERE LOW IN VOLTAGE DURING COMPRESSIONS. THEREFORE, THE BOARD RAN FRO A FEW COMPRESSIONS THEN STOPPED AND DISPLAYED "REPLACE BATTERY". CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED BASED ON THIS ARCHIVE DATA REVIEW. FUNCTIONAL TESTING THE PLATFORM RAN WITH AN IN-HOUSE TEST BATTERY FOR 10 MINUTES ON A LARGE RESUSCITATION TEST FIXTURE (LRTF) AND FOR 35 MINUTES WITH A TEST MANIKIN. NO PROBLEMS WERE FOUND DURING COMPRESSIONS. THE PLATFORM PASSED FINAL TESTING. IN SUMMARY THE REPORTED COMPLAINT WAS CONFIRMED BASED ON REVIEW OF THE ARCHIVE DATA, HOWEVER THE FAILURE COULD NOT BE REPRODUCED DURING FUNCTIONAL TESTING. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A (B)(6) YEAR OLD FEMALE THE AUTOPULSE RESUSCITATION SYSTEM (S/N (B)(4)) EXPERIENCED SHORT RUN TIMES. MANUAL CPR WAS PERFORMED. NO FURTHER INFO WAS PROVIDED AND NO ADVERSE PAT SEQUELAE WAS REPORTED. NOTE: AUTOPULSE PLATFORM S/N (B)(4), MFR REPORT #3003793491-2013-00679. NIMH BATTERY S/N UNK, MFR REPORT #3003793491-2013-00680. NIMH BATTERY S/N UNK, MFR REPORT #3003793491-2013-00681.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259225 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MANUAL COMPRESSIONS