BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE? NIMH BATTERY

    MDR report key: 3182046 · Received June 21, 2013

    Report

    Report Number
    3003793491-2013-00696
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE NIMH BATTERY GAVE LOW RUN TIME ON THE AUTOPULSE PLATFORM OF APPROXIMATELY 10 MINUTES. NO ADVERSE SEQUELAE WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282192 AUTOPULSE? NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702

    Patients

    Seq Age Sex Outcome Treatment
    1