BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLUSE NIMH BATTERY

    MDR report key: 3150330 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00637
    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 BATTERY WITH SN (B)(4) WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. VISUAL INSPECTION REVEALED NO ANOMALIES. CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. THE RETURNED BATTERY FAILED TESTING. BASE 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 REPORT NUMBERS: 3003793491-2013-00634 FOR AUTO PULSE RESUSCITATION SYS MODEL 100 WITH SN (B)(4), 3003793491-2013-00635 FOR AUTO PULSE NIMH BATTERY WITH SN (B)(4) AND 3003793491-2013-00636 FOR AUTO PULSE 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. PT WAS REPORTED TO BE OF AVERAGE SIZE. NO OTHER SPECIFIC INFO WAS PROVIDED OTHER THAN A REPORT OF SHORT RUN TIME. THE USER REVERTED TO MANUAL CPR. NO ADVERSE PT 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
    237744 AUTOPLUSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC. 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR MANUAL CPR