BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2932998 · Received December 31, 2012

    Report

    Report Number
    3003793491-2012-00655
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    October 2, 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

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED COMPRESSIONS AFTER 10 MINUTES DUE TO THIS FAULTY BATTERY. THE USER PERFORMS PROPER BATTERY MAINTENANCE. BATTERY CHARGED AND ROTATION TO THE DEVICE EVERY MORNING. ALSO, TEST CYCLED ONE PER MONTH. ON (B)(6) 2012 THE DEVICE STOPPED COMPRESSION WITH 10 MINUTES. THE USER CONFIRMED SIGN OF "READY" AT CHARGER WHEN REPLACING THE BATTERY BETWEEN CHARGER AND AUTOPULSE AT 9:00 AM ON (B)(6) 2012.

    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