BEUDAMED
    FDA Adverse Event Other Summary report: N

    4500 MRI PULSE OXIMETER

    MDR report key: 710322 · Received November 23, 2005

    Report

    Report Number
    1051786-2005-00011
    Event Type
    Other
    Date Received
    November 23, 2005
    Report Date
    February 8, 2002
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE USER FACILITY, THE EVENT OCCURRED "A COUPLE OF WEEKS" PRIOR TO THE DATE THE INCIDENT WAS ACTUALLY REPORTED TO THE MFR. IT WAS REPORTED TO THE MFR THAT A PT MONITOR WAS BROUGHT INTO THE MRI MAGNET ROOM FOR USE ON A PT. THE UER FACILITY REPORTED THAT THE PT ABOUT TO BE SCANNED HAD BEEN OVER-SEDATED AND NEEDED SPO2 MONITORING IN A HURRY. THE MRI TECHNOLOGIST PLACED THE PT MONITOR ON THE COUNTER WHICH WAS 5 - 6 FEET AWAY FROM THE MRI SCANNER. THE PT MONITOR'S POWER ADAPTER, WHICH WAS NOT SECURED TO THE AC WALL SOCKET, FLEW TOWARD THE MRI MAGNET AND STUCK ON THE MAGNET'S SIDE. THE USER FACILITY REPORTED THAT THERE WERE NO INJURIES SUSTAINED BY THE STAFF OR THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4500 MRI PULSE OXIMETER PT MONITOR DQA INVIVO CORPORATION 3109-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other