BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 731599 · Received June 21, 2006

    Report

    Report Number
    731599
    Event Type
    Other
    Date Received
    June 21, 2006
    Date of Event
    May 2, 2006
    Report Date
    June 21, 2006
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TAKEN FROM PEDIATRICS TO MOBILE MRI IN ORDER TO PERFORM SCAN. PATIENT WAS UNDER SEDATION SO THEY WERE CONNECTED TO A PULSE OXIMETER (NONIN MEDICAL INC MODEL 8604). MRI TECH QUESTIONED HOSPITAL NURSE AS TO WHETHER THE PULSE OXIMETER WAS MRI SAFE AND WAS TOLD THAT IT WAS; THEY HAD USED THIS MACHINE IN MRI FOR ALL SEDATED PATIENTS. PATIENT WAS PLACED ON TABLE AND THE TABLE WAS ADVANCED INTO THE MAGNET TO INITIATE SCAN. AT THIS POINT, THE MRI TECH NOTICED THE PULSE OXIMETER BEING ATTRACTED TO THE MAGNET. THE TECH JUMPED FORWARD INTO THE MAGNET AND COVERED THE PATIENTS BODY AND HEAD WITH HER BODY. PATIENT SUSTAINED NO INJURY HOWEVER THE TECH RECEIVED A LACERATION ON ONE OF THE FINGERS ON HER LEFT HAND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR