BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 886248 · Received July 25, 2007

    Report

    Report Number
    1220063-2007-00017
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Report Date
    July 23, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT WHILE USING OUR DELTA PATIENT MONITORS, THEY REPORTED THAT THE REAR COVER, (BATTERY COMPARTMENT) WAS HOT AND THE INTERNAL BATTERY SHOWED SIGNS OF OVERHEATING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA PATIENT MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. MS13466 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR