BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE OXIMETER

    MDR report key: 14555 · Received July 7, 1994

    Report

    Report Number
    MW1002747
    Event Type
    Other
    Date Received
    July 7, 1994
    Date of Event
    May 13, 1994
    Report Date
    June 24, 1994
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT HAD PULSE OXIMETER SENSOR ON RIGHT INDEX FINGER DURING MRI OF BRAIN. AT THE END OF EXAM SHE SAID SHE FELT A BURNING ON HER FINGER. TECH CHECKED HAND AND OTICED A REDDENING ON PAD OF INDEX FINGER. NO BLISTER AT ANY TIME. PT WAS NOT SMALL ENOUGH TO HAVE SENSOR IN THE MRI BORE WITH HER YET SHE DETECTED THE BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETER PULSE OXIMETER DQA NONIN MEDICAL, INC. 8604D-L

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other