BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA S/5 M-OSAT

    MDR report key: 408342 · Received July 30, 2002

    Report

    Report Number
    9610105-2002-00005
    Event Type
    Other
    Date Received
    July 30, 2002
    Report Date
    July 30, 2002
    Manufacturer
    INSTRUMENTARIUM CORP., DATEX-OHMEDA DIVISION
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DATEX-OHMEDA WAS INFORMED IN JULY 2002 TAHT A FEW WEEKS AGO, THE HOSPITAL HAD AN INCIDENT IN WHICH A PATIENT BECAME BLUE AS A RESULT OF A TECHNICAL PROBLEM WITH THE VENTILATOR. THE MONITOR BEING USED AT THE TIME STILL SHOWED A SATURATION OF 96% - 97%. AFTER SEEING THE PROBLEM, THE USERS CHANGED THE SENSOR (OXY-F4-H), WITH THE OTHER SENSOR (0380-1000-081) THEY GOT THE SAME SPO2 OF 97%. AFTER WATCHING THE PATIENT'S COLOR THEY TOOK A BLOOD SAMPLE TO THE ANALYZER AND GOT A PO2 READING OF 54MMHG. THEN THEY TOOK THE MONITOR CARDIOCAP II AND THE SP02 READING WAS 72%. THE NEXT STEP WAS ANOTHER ANALYZER AT THE LAB AND PO2 WAS THEN 52MMHG. THE DEVICE WAS TAKEN OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 M-OSAT DATEX-OHMEDA S/5 OXYGEN SATURATION MODULE DQA INSTRUMENTARIUM CORP., DATEX-OHMEDA DIVISION M-OSAT *

    Patients

    Seq Age Sex Outcome Treatment
    1 5.5 YR Other DATEX-OHMEDA OXIMETER SENSORS OXY-F4-H, FLEXII.