BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA XL

    MDR report key: 897506 · Received August 14, 2007

    Report

    Report Number
    1220063-2007-00024
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    July 10, 2007
    Report Date
    August 13, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS INC. HAS RECEIVED INFORMATION FROM A CUSTOMER THAT REPORTED AN EVENT OCCURRED WHILE MONITORING A PATIENT'S SPO2 VALUES USING OUR SC9000 PATIENT MONITOR. THE CUSTOMER DID INDICATE THAT THE PATIENT WAS ALREADY IN BREATHING DISTRESS AND MULTIVISCERAL FAILURE BEFORE THIS EVENT: AND NO ADVERSE CONSEQUENCES ARE ATTRIBUTED TO THE EVENT. THE PATIENT WAS THEN MONITORED USING OUR DEVICE FOR SPO2 AND THE CUSTOMER QUESTIONED THE HIGHER THAN EXPECTED SPO2 VALUE, WHICH WAS REPORTED TO BE 95%. AS A RESULT, THE CUSTOMER PERFORMED A BLOOD GAS ANALYSIS AS A COMPARATIVE MEANS AND DETERMINED THAT HYPOXY (LOW SAT) WAS NOT DETECTED BY THE SC9000 MONITOR, BUT SHOWN ONLY WITH THE SECONDARY BLOOD ANALYSIS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. SC9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention