BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3150319 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00631
    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 05/14/2013 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), 3003793491-2013-00632 FOR AUTO PULSE NIMH BATTERY WITH SN (B)(4) AND 3003793491-2013-00633 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
    238296 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR MANUAL CPR