BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2971897 · Received January 16, 2013

    Report

    Report Number
    3003793491-2013-00104
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT OF "BATTERY HAS FAILED TESTING. UNABLE TO CLEAR RED LIGHT" WAS NOT VERIFIED. DEVICE WAS NOT RETURNED DESPITE 3 ATTEMPTS TO GET THE DEVICE BACK. ONE ATTEMPT WAS MADE ON (B)(4), 2012, A SECOND ATTEMPT WAS MADE ON (B)(4) 2012, AND A FINAL ATTEMPT WAS MADE ON (B)(4) 2012. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BATTERY SN (B)(4) FAILED TESTING AND THAT THE RED LED LIGHT WOULD NOT CLEAR. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25501 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1