BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2941738 · Received December 27, 2012

    Report

    Report Number
    3003793491-2012-00543
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NIMH BATTERY (S/N (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. THE CUSTOMER IS NOT FOLLOWING PROPER BATTERY MANAGEMENT PROCEDURES OF DAILY SYSTEM CHECKS AND BATTERY SWAP. LOW VOLTAGE BATTERY HAVE BEEN USED REPEATEDLY. ON (B)(6) 2012, THIS BATTERY WAS USED REPEATEDLY FOR DEPLOYMENT WHICH WAS NOT FULLY CHARGED WHICH MAY HAVE CAUSED THE REPORTED COMPLAINT OF "USER ADVISORY 17." AFTER THE BATTERY WAS CHARGED AND TEST CYCLED, IT PASSED TESTING. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED COMPRESSION AFTER 10 MINUTES. CUSTOMER WILL RETURN THE DEVICE AND TWO BATTERIES (S/N (B)(4)). CUSTOMER ALSO REQUESTED INVESTIGATION OF THIS FAILURE AND REPAIR OF USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other