BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2883780 · Received November 15, 2012

    Report

    Report Number
    3003793491-2012-00226
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVAL. IF PRODUCT IS RETURNED TO THE MFR, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOPULSE NIMH BATTERY WITH S/N (B)(4) FAILED DURING TESTING IN THE CHARGER. THERE WAS NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other