BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LI-ION BATTERY

    MDR report key: 2915891 · Received December 6, 2012

    Report

    Report Number
    3003793491-2012-00507
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY FAILED TWICE IN THE CHARGER AND IS SHOWING EMPTY ON AUTOPULSE, YET THE TEST BUTTON ON THE TOP OF THE BATTERY IS INDICATING FULL AND THAT BATTERY HAS NOT BEEN USED CLINICALLY. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other