BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROTREND SENSOR

    MDR report key: 376884 · Received February 11, 2002

    Report

    Report Number
    9612233-2002-00001
    Event Type
    Other
    Date Received
    February 11, 2002
    Date of Event
    November 3, 2001
    Report Date
    November 8, 2001
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A SALES REP. REPORTED THAT THE SENSOR READINGS WERE NOT CONCURRENT WITH THE SITUATION OF THE PATIENT. SALES REP AND SURGEON BELIEVED SENSOR WAS FAULTY. IT WAS REMOVED FROM USE. FURTHER INFORMATION WAS REQUESTED BY DEVICE MANUFACTURER-DIAMETRICS MEDICAL LIMITED. IN JANUARY 2002, SALES REP REPORTED THAT SURGERY HAS GONE WELL. O2 NUMBERS WERE HIGH, BUT THEN CONTINUED ON DOWNWARD SPIRAL DURING NEXT FEW HOURS FROM 110 TO 70 TO 1 OR 0. SENSOR REMOVED AND DISCARDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROTREND SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL, LTD. C7004S 814

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR