BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION

    MDR report key: 1579939 · Received January 9, 2010

    Report

    Report Number
    1051786-2010-00001
    Event Type
    Death
    Date Received
    January 9, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 5, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K040915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFO DOES NOT INDICATE THAT THE MONITOR MALFUNCTIONED, AND THERE IS NO INDICATION THAT THE MONITOR WAS A FACTOR IN THE PT CODING. THE DEVICE MFR IS CURRENTLY INVESTIGATING THIS INCIDENT AND WILL FILE A SUPPLEMENTAL REPORT AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED TO THE DEVICE MFR THAT THE PT ARRIVED IN THE MRI AREA IN AN "UNSTABLE" CONDITION AND THAT "HIS HANDS AND FEET APPEARED GRAY IN COLOR BEFORE THE SCAN WAS PERFORMED". THE NURSE REPORTED SHE NEVER REALLY HAD A GOOD BASELINE ECG READING AND THAT SHE COULD NOT TELL WHAT WAS GOING ON WITH THE ECG, AS IT WAS "JUMBLED". DURING THE MRI SCAN, THE NURSE TOOK THE PT'S PULSE AND THEN REQUESTED THAT THE PT BE REMOVED FROM THE MRI. A CODE WAS CALLED AND THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION MAGNITUDE MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3150M

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death