BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3150329 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00634
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 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 WAS RETURNED TO ZOLL CIRCULATION ON (B)(6) 2013 FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE FRONT ENCLOSURE AND BATTERY LOCK WERE DAMAGED. ARCHIVE DATA REVIEW SHOWED THAT ALL THREE BATTERIES WITH SN (B)(4) WERE LOW IN VOLTAGE DURING COMPRESSIONS. THEREFORE, THE BOARD RAN FOR A FEW COMPRESSIONS THEN STOPPED AND DISPLAYED "REPLACE BATTERY." CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. FUNCTIONAL TESTING WAS UNABLE TO REPRODUCE THE REPORTED COMPLAINT. 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. BASED ON THE EVALUATION RESULTS, A PROBABLE ROOT CAUSE FOR CUSTOMER'S REPORTED COMPLAINT MAY BE DUE TO A BATTERY PROBLEM; HOWEVER, A DEFINITIVE ROOT CAUSE FOR THE BATTERY PROBLEM COULD NOT BE DETERMINED. PLEASE SEE THE FOLLOWING RELATED MFR. REPORTS: #3003793491-2013-00635 FOR AUTOPULSE NIMH BATTERY WITH SN (B)(4), #3003793491-2013-00636 FOR AUTOPULSE NIMH BATTERY WITH SN (B)(4), #3003793491-2013-00637 FOR AUTOPULSE NIMH BATTERY WITH SN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM WAS USED ON A (B)(6) MALE IN CARDIAC ARREST. PATIENT WAS REPORTED TO BE OF AVERAGE SIZE. NO OTHER SPECIFIC INFORMATION WAS PROVIDED OTHER THAN A REPORT OF SHORT RUN TIME. THE USERS REVERTED TO MANUAL CPR. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. THE CUSTOMER UTILIZES A 3-BATTERY ROTATION AND STATED THAT THEY TEST CYCLE THEIR BATTERIES MONTHLY BUT ROTATE BATTERIES EVERY 5 DAYS. THE CUSTOMER WAS INFORMED THAT THE CURRENT RECOMMENDATIONS ARE TO ROTATE THE BATTERIES DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237936 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR MANUAL CPR