BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE OXIMETER

    MDR report key: 14556 · Received July 7, 1994

    Report

    Report Number
    MW1002746
    Event Type
    Other
    Date Received
    July 7, 1994
    Date of Event
    June 10, 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 THE PULSE OXIMETER SENSOR ON THE INDEX FINGER OF THE RIGHT HAND. DURING EXAM HE STATED THAT IT FELT LIKE IT WAS BURNING. TECH TOOK THE SENSOR OFF. AT THE END OF THE MRI EXAM PT HAD A BLISTER ON THE RIGHT INDEX FINGER. PT IS SHORT AND LARGE, JUST BARELY FIT IN ANOTHER MFR'S MRI. SENT PULSE OXIMETER TO MFR FOR QA ON MACHINE.

    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 59 YR Other