BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA

    MDR report key: 871226 · Received June 26, 2007

    Report

    Report Number
    1220063-2007-00014
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Report Date
    June 25, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM TE FIELD INDICATING THAT ONE OF OUR GAMMA PATIENT MONITORS HAD EMITTED SMOKE DUE TO A POSSIBLE SHORT CIRCUIT OF THE INSTALLED LITHIUM BATTERY. WE HAVE REQUESTED THE CITED MONITOR AND BATTERY TO BE RETURNED TO OUR FACTORY FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA GAMMA PATIENT MONITOR DRG DRAEGER MEDICAL SYSTEMS, INC. NOT INDICATED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR