BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 3771509 · Received April 24, 2014

    Report

    Report Number
    3003793491-2014-00210
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE BATTERY (S/N (B)(4)) WAS RETURNED AND EVALUATED. EXTERNAL VISUAL INSPECTION SHOWED NO DAMAGES. BATTERY POWER WAS MEASURED BEFORE FUNCTIONAL TESTING AND WAS FOUND TO BE 1601.1 WATTS. FOLLOWING CHARGING OF THE BATTERY, THE POWER WAS MEASURED TO BE 1792.0 WATTS. FOLLOWING CHARGING, THE BATTERY WAS FUNCTIONALLY TESTED WITH A TEST AUTOPULSE PLATFORM AND TEST MANIKIN. THE AUTOPULSE PLATFORM RAN UNINTERRUPTED FOR 42 MINUTES WITH NO ISSUES OBSERVED. THE REPORTED SHORT RUNTIME COULD NOT BE DUPLICATED. BASED ON THE EVALUATION RESULTS, THERE WERE NO ISSUES OR ANOMALIES NOTED WITH THE RETURNED BATTERY THAT COULD HAVE CONTRIBUTED TO THE REPORTED SHORT RUNTIME. BASED ON THE EVALUATION RESULTS, A CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT AN AUTOPULSE LI-ION BATTERY WAS GIVING LOW RUN TIMES, TYPICALLY 10 MINUTES. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249313 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION, INC 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1