BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3150331 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00633
    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: 3003793491-2013-00630 FOR AUTO PULSE RESUSCITATION SYS MODEL 100 WITH SN (B)(4), 3003793491-2013-00631 FOR AUTO PULSE NIMH BATTERY WITH SN (B)(4) AND 3003793491-2013-00632 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) FEMALE IN CARDIAC ARREST. PT SIZE WAS AVERAGE. THE PLATFORM COMPRESSED FOR 2 MINUTES AND WAS STOPPED BY THE OPERATORS. WHEN THEY TRIED TO RESTART, THE LIFEBAND WOULD RESIZE, PERFORM 5 COMPRESSIONS AND THEN STOP. THE DISPLAY DARKENED AND PROMPTED "REPLACE BATTERY". THE USERS ATTEMPTED TO CONTINUE A COUPLE MORE TIMES BUT 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
    238154 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR MANUAL CPR