BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVIVO CORPORATION PRECESS (3160 SERIES) MRI PATIENT MONITORING SYSTEM

    MDR report key: 2033304 · Received March 24, 2011

    Report

    Report Number
    1051786-2011-00002
    Event Type
    Other
    Date Received
    March 24, 2011
    Report Date
    February 22, 2011
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS AN ALLEGATION THAT THE MONITOR WAS BEING DRAWN INTO THE MAGNET FOLLOWING REPAIR OF THE DEVICE. THERE IS NO INDICATION IN THE COMMUNICATION REC'D FROM THE USER THAT USE OF THE DEVICE WAS OUTSIDE OF THE DEVICE'S LABELING. THEREFORE, WE ARE REPORTING THIS OCCURRENCE. THE DEVICE MFR'S TECHNICAL SUPPORT ADVISED THE USER TO ENSURE THAT THE DEVICE REMAINED BEHIND THE 5000 GAUSS FIELD LINE AND TO ALWAYS ENSURE THAT THE WHEELS ARE IN THE LOCKED POSITION WHEN THE DEVICE IS LEFT UNATTENDED (PER THE INSTRUCTIONS FOR USE). THE USER WAS ALSO ADVISED THAT NO ACTIVITY DONE DURING THE REPAIR OF THE DEVICE WOULD HAVE CAUSED IT TO BE DRAWN TOWARDS THE MAGNET. THE USER REPORTED THAT THEY WERE GOING TO CHECK WITH THE STAFF AND MAKE SURE THAT THE GUIDELINES PROVIDED IN THE INSTRUCTIONS FOR USE ARE BEING FOLLOWED. THE DEVICE MFR IS STILL INVESTIGATING THIS INCIDENT AND WILL FILE A COMPLETE REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE USER FACILITY'S CLINICAL ENGINEERING DEPARTMENT REPORTED THAT THE DEVICE'S BASE WAS BEING DRAWN TO THE MRI MAGNET AFTER BEING RETURNED FROM BENCH REPAIR. THERE WAS NO REPORTED PT INVOLVEMENT.

    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