BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3182305 · Received June 10, 2013

    Report

    Report Number
    3003793491-2013-00683
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE BATTERY IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. INVESTIGATION IS STILL IN PROGRESS AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED. PLEASE SEE THE FOLLOWING RELATED MFR. REPORTS: NUMBER 3003793491-2013-00682 FOR AUTOPULSE RESUSCITATION SYSTEM MODEL 100 WITH SN (B)(4). NUMBER 3003793491-2013-00684 FOR AUTOPULSE NIMH BATTERY WITH SN (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR RETURNED AUTOPULSE BATTERY WITH(B)(4) AS FOLLOWS:EVALUATION OF THE BATTERY CONFIRMED THE FOLLOWING: A CHARGE/TEST CYCLE WAS PERFORMED ON THE BATTERY, AFTER WHICH THE BATTERY WAS RE-TESTED. TEST RESULTS SHOW THAT THE BATTERY FAILED THE OUTPUT WATTS. BASED ON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING MORNING CHECK-OFFS WITH THE ON-DUTY CREW, A PARAMEDIC STUDENT SWITCHED BOTH AUTOPULSE NIMH BATTERIES. THE CREW RESPONDED TO A CARDIAC ARREST AT APPROXIMATELY 9:33 AM AND REPORTED THAT THE AUTOPULSE PLATFORM STOPPED BOTH TIMES WITHOUT WARNING. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. MFR REQUESTED ADDITIONAL INFORMATION ON (B)(4) 2013, HOWEVER, CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261762 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC. 8700-0702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1