BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONIN SA 02 MONITOR

    MDR report key: 16327 · Received January 24, 1994

    Report

    Report Number
    16327
    Event Type
    Other
    Date Received
    January 24, 1994
    Date of Event
    August 20, 1993
    Report Date
    November 12, 1993
    Manufacturer
    NONIN MED INC.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MRI C SPINE AND NEEDED TO BE MONITORED WITH PULSE OXIMETER. IT WAS PLACED ON FINGER (LEFT LITTLE FINGER) AS APPROPRIATE. HOWEVER, PATIENT WAS IN TRACTION AND ARMS HAD TO BE AT HIS SIDE. THIS LEFT THE PULSE OXIMETER INSIDE THE BOOR. UPON COMPLETION OF THE MRI A WHITE AREA APPROXIMATELY 1 CM WAS NOTED ON LEFT LITTLE FINGER. PHYSICIAN EXAMINED AND ORDERED OINTMENT. WE DID NOT FEEL IT WAS A REPORTABLE OCCURRENCE AT THE TIME OF EVENT BUT HAVE RECEIVED FURTHER INFORMATION THAT INDICATE IT MAY BE. THUS, THE REASON FOR THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN SA 02 MONITOR SA 02 MONITOR NONIN MED INC. 8604D N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other