BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION

    MDR report key: 1670312 · Received April 27, 2010

    Report

    Report Number
    1051786-2010-00012
    Event Type
    Death
    Date Received
    April 27, 2010
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THEY TOOK A LONG TIME TO PREP THE PT BECAUSE INITIALLY THE ECG WAS TOO SMALL AND ARTIFACT WAS PRESENT BEFORE THEY ENTERED THE MRI SCANNER. A DEVICE MANUFACTURER REPRESENTATIVE WAS PRESENT DURING THE REPORTED EVENT AND WORKED WITH THE USER RECONFIGURING/TROUBLESHOOTING THE DEVICE'S SETTINGS AND PLACING THE ECG ELECTRODES DIFFERENTLY IN ORDER TO GET AN ACCURATE AND CONSISTENT ECG ON THE DEVICE. THE USER CLAIMED THAT IT WAS CRUCIAL FOR THEM TO OBTAIN AN ACCURATE ECG WITH THE PT DUE TO HIS MEDICAL CONDITION AND THAT THEY TOOK THE EXTRA TIME TO MAKE SURE THEY COULD GET ONE BEFORE ENTERING THE MRI SCANNER. ONCE THE PT WAS IN THE MRI, THE USER REPORTED THAT THEY HAD NO PROBLEMS MONITORING THE PT, AND THEY WERE ABLE TO MONITOR BLOOD PRESSURE, SPO2 AND ECG. THE DEVICE MANUFACTURER IS CURRENTLY INVESTIGATING THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPIRED AFTER BEING TRANSFERRED TO A GURNEY FOR TRANSPORT OUTSIDE THE MRI MAGNET ROOM. IT WAS REPORTED THAT, AT THE TIME OF THE EVENT, THE PT WAS CONNECTED TO A TRANSPORT MONITOR AND NOT THE MEDICAL DEVICE LISTED IN THIS REPORT. THE TRANSPORT MONITOR IS NOT MANUFACTURED BY INVIVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION PRECESS (3160 SERIES) MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death