BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2983186 · Received January 31, 2013

    Report

    Report Number
    3003793491-2013-00079
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    September 28, 2012
    Report Date
    October 11, 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

    BATTERY(IES) WERE NOT RETURNED, THEREFORE, AND INVESTIGATION CANNOT BE PERFORMED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY STOPPED COMPRESSIONS FOR BATTERY RELATED REASONS. ISSUE COULD NOT BE DUPLICATED USING OTHER BATTERIES. ARCHIVE FILE INDICATES THAT THESE ERRORS OCCURRED ON (B)(6) 2011, (B)(6) 2012. EVENT 1, (B)(6). 2011, MFR REPORT: 3003793491-2013-00077; EVENT 2, (B)(6) 2012, MFR REPORT: 3003793491-2013-00078; EVENT 3, (B)(6) 2012, MFR REPORT: 3003793491-2013-00079. IT WAS ALSO REPORTED THAT THE PLATFORM INDICATED USER ADVISORY 02 (COMPRESSION TRACKING ERROR), USER ADVISORY 27 (ENCODER FAULT (>300RPM)) AND USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET). AUTOPULSE PLATFORM, MFR REPORT# 3003793491-2013-00264. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43789 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other