BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA

    MDR report key: 870707 · Received June 25, 2007

    Report

    Report Number
    1220063-2007-00012
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Date of Event
    May 16, 2007
    Report Date
    June 22, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION OF A PRODUCT PROBLEM INVOLVING OUR DELTA PATIENT MONITOR AND SP02 SENSOR. THE CUSTOMER REPORTED THAT THE DRAEGER REUSABLE SPO2 CONNECTED TO OUR DELTA MONITOR WAS FOUND LYING ON FLOOR AND THE SPO2 CURVE WAS DISPLAYED UNCHANGED ON THE MONITOR. THE SPO2 VALUE WAS 95, EVEN THOUGH THE SENSOR WAS NOT ON THE PATIENT'S FINGER AND NO ALARM WAS INDICATED ON THE MONITOR. THE CUSTOMER ALSO REPORTED THAT THE CONDITION WAS NOT REPRODUCIBLE WHEN A SIMULATION OF A SENSOR DETACHMENT WAS PERFORMED. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR