BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2983159 · Received January 31, 2013

    Report

    Report Number
    3003793491-2013-00168
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NIMH BATTERY (B)(4) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE BATTERY SHOWED NO DISCREPANCIES. FURTHERMORE, THE REPORTED PROBLEM WAS NOT CONFIRMED. THE BATTERY PASSED TESTING. HOWEVER, IT WAS NOTED THAT THE BATTERY WAS NOT PROPERLY MAINTAINED (I.E. TEST CYCLED ON A MONTHLY BASIS). THE AUTOPULSE SYSTEM LABELING REQUIRES THE USER TO "TEST CYCLE" EACH BATTERY ONCE A MONTH. NOT FOLLOWING THE RECOMMENDED BATTERY MAINTENANCE MAY RESULT IN FASTER AGING OF THE BATTERY. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERIES HAVE FAILED TESTING. BATTERY SN: (B)(4), MFR REPORT# 3003793491-2013-00165. BATTERY SN: (B)(4), MFR REPORT# 3003793491-2013-00166. BATTERY SN: (B)(4), MFR REPORT# 3003793494-2013-00167. BATTERY SN: (B)(4), MFR REPORT# 3003793491-2013-00168. BATTERY SN: (B)(4), MFR REPORT# 3003793491-2013-00169.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43798 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1