BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 767782 · Received September 15, 2006

    Report

    Report Number
    2183646-2006-00002
    Event Type
    Other
    Date Received
    September 15, 2006
    Date of Event
    May 2, 2006
    Report Date
    September 13, 2006
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NONIN RECEIVED MEDWATCH 2200190000-2006-8006 FROM THE FDA ON 9/11/06 (LETTER POST MARKED 9/5/06). NONIN RECEIVED A LETTER FROM THE FDA DATED 7/14/06, REQUESTING MORE INFO ON 9/13/06 (LETTER POST MARKED 9/7/06). NONIN WAS NOT NOTIFIED BY USER FACILITY OF ADVERSE EVENT, NOR WERE WE NOTIFIED TO REPAIR THE UNIT.

    Description of Event or Problem · 1

    EVENT DESC: PT WAS TAKEN FROM PEDIATRICS TO MOBILE MRI IN ORDER TO OPERFORM SCAN. PT WAS UNDER SEDATION SO THEY WERE CONNECTED TO A PULSE OXIMETER (NONIN MEDICAL INC MODEL 8604). MRI TECH QUESTIONED HOSP 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 PTS. PT 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 PTS BODY AND HEAD WITH HER BODY. PT 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 * PULSE OXIMETER DQA NONIN MEDICAL, INC. 8604 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR