BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA XL

    MDR report key: 869526 · Received June 21, 2007

    Report

    Report Number
    1220063-2007-00011
    Event Type
    Injury
    Date Received
    June 21, 2007
    Date of Event
    March 21, 2007
    Report Date
    June 20, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM OUR LOCAL DISTRIBUTOR THAT A CUSTOMER, HOSP FEELS THAT OUR MEASURED VALUES FOR SPO2 ARE FREQUENTLY SHOWING FALSE HIGH VALUES. THE CUSTOMER HAS INDICATED THAT THE REPORTED EVENT RESULTED IN A DETERIORATION OF THE PT'S STATE OF HEALTH (HYPOXIA).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other