BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2983194 · Received January 31, 2013

    Report

    Report Number
    3003793491-2013-00165
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NIMH BATTERY SN (B)(4) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE BATTERY SHOWS NO DISCREPANCIES. FURTHERMORE, THE REPORTED PROBLEM WAS NOT CONFIRMED. BATTERY PASSED TESTING. 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
    43830 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1