BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNITUDE MRI MONITOR

    MDR report key: 624274 · Received August 1, 2005

    Report

    Report Number
    1051786-2005-00006
    Event Type
    Death
    Date Received
    August 1, 2005
    Date of Event
    June 4, 2005
    Report Date
    July 25, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED T HAT APPROXIMATELY 40 MINUTES INTO AN MRI SCAN USING A GE SIGNA EXCITE (1.5T), THE 3150 WAS REPORTEDLY NOT GIVING BLOOD PRESSURE READINGS AND "CYCLED" 4 TIMES. THE UNIT WAS REPORTEDLY GIVING PULSE OX READINGS OF 93, WHICH WAS CONSISTENT WITH THE RANGE OF 91 TO 94 THAT THE UNIT WAS READING PRIOR TO THE 4 UNIT "CYCLES". IT WAS REPORTED, HOWEVER, THAT THE PT WAS PULLED OUT OF THE MRI "PULSELESS". DURING THE SCAN THE PT'S PULSE OX, NIBP AND ECG WERE BEING MONITORED, BUT ETCO2 WAS NOT. THE 3150 MONITOR WAS APPROXIMATELY 4 FEET TO THE SIDE OF THE SCANNER AND THE ANESTHESIOLOGIST WAS APPROXIMATELY ANOTHER 4 FEET AWAY READING THE SCREEN. THE LIGHTING WAS REPORTEDLY LOW IN THE MRI ROOM AND THE PT WAS SEDATED. IT WAS ALSO REPORTED THAT THE 3155 REMOTE DISPLAY CONNTROLLER WAS NOT BEING USED IN CONJUNCTION WITH THE 3150.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNITUDE MRI MONITOR PATIENT MONITORING DEVICE DRT INVIVO CORPORATION 3150 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death