BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA XL

    MDR report key: 871224 · Received June 26, 2007

    Report

    Report Number
    1220063-2007-00013
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Date of Event
    May 16, 2007
    Report Date
    June 22, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT OR DELTA XL PATIENT MONITOR DISPLAYED A SP02 MEASUREMENT OF 98%; HOWEVER, THE ATTENDING CLINICIAN REPORTED THAT THE PATIENT WAS CYANOTIC (BLUISH SKIN COLOR). A SECOND MONITOR (DIFFERENT MANUFACTURER) WAS USED TO OBTAIN THE PATIENT'S SP02 VALUES WHICH WERE MEASURED AT <70%. THE PATIENT WAS TRANSFERRED TO ANOTHER BED AND MONITORED WITH A DIFFERENT MANUFACTURER'S DEVICE WITH NO FURTHER PROBLEMS REPORTED.

    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 Required Intervention