BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2982277 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00224
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY PREMATURELY REACHED END OF LIFE DUE TO INADEQUATE MAINTENANCE. BATTERY WAS NOT TEST CYCLED AS REQUIRED, IT WAS ONLY TEST CYCLED 3 TIMES. NO ADVERSE EVENT REPORTED. ON (B)(6) 2013 - UPON QA REVIEW FOR CLOSURE, IT WAS DETERMINED THAT THIS CCR IS TO BE RECLASSIFIED FROM A NON-COMPLAINT (SVC REPORT) TO PRODUCT COMPLAINT AND REPORT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35480 AUTOPULSE NIMH BATTERY CARDIAC NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other