BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVIVO CORPORATION

    MDR report key: 1409316 · Received June 29, 2009

    Report

    Report Number
    1051786-2009-00004
    Event Type
    Other
    Date Received
    June 29, 2009
    Date of Event
    April 9, 2009
    Report Date
    June 5, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO MALFUNCTION OF THE DEVICE. THE MRI SUITE WERE THE DEVICE IS LOCATED WAS STILL UNDER CONSTRUCTION ADN THE DEVICE WAS NOT IN USE AT THE TIME OF THE INCIDENT. THE USER FACILITY REPORTED THAT THE PATIENT MONITOR HAS NO CAUTION OR WARNING SIGNS ON THE MONITOR ITSELF. THE DEVICE DOES NOT HAVE WARNING LABELS ON IT, WHICH ARE NOT OBSCURED BY THE MOUNTED CONFIGURATION AND FULLY VISIBLE TO THE USER. IN ADDITION TO THE MR CONDITIONAL LABELS ON BOTH THE FRONT AND BACK OF THE DEVICE, THE DEVICE ALSO HAS A WARNING LABEL DEPICTING THE DISTANCE THE DEVICE SHOULD REMAIN AWAY FROM THE MRI MAGNET (OUTSIDE THE 2,000 GAUSS (0.2T) FIELD LINE). THESE WARNINGS ARE ALSO PRESENT IN THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE. THE PRESENCE OF THESE LABELS ON THE DEVICE AT THE USER FACILITY WAS CONFIRMED BY BOTH THE SALES REPRESENTATIVE AND THE DEVICE MANUFACTURER'S FIELD SERVICE STAFF. IT IS BELIEVED THAT THE USERS WERE EITHER MOVING THE PATIENT TABLE/DEVICE MOUNT FOR CONSTRUCTION PURPOSES OR TRYING TO MIMIC USE OF THE PATIENT TABLE/DEVICE MOUNT IN PREPARATION FOR WHEN THE MRI SUITE WAS FULLY OPERATIONAL. IN DOING SO AND BY MOVING THE PATIENT TABLE/DEVICE MOUNT, THE USERS VIOLATED THE MR CONDITIONAL PROVISIONS OF THE DEVICE AS STATED ON THE DEVICE'S LABELING. AS INDICATED ABOVE, THE MRI SUITE WHERE THE DEVICE WAS LOCATED WAS STILL UNDER CONSTRUCTION AT THE TIME OF THE INCIDENT. ADDITIONALLY, THE INCIDENT OCCURRED AFTER THE DEVICE WAS INITIALLY INSTALLED, BUT BEFORE THE USERS WERE TRAINED ON THE DEVICE. THE DATE THE USER TRAINING OCCURRED WAS DICTATED BY THE USER AND COINCIDED WITH THE FINAL STAGES OF THE CONSTRUCTION OF THE MRI SUITE. TRAINING THE USERS, WHICH OCCURRED (B)(6) 2009, COVERED GENERAL USE OF THE DEVICE AND INCLUDED DETAINED DISCUSSIONS ON THE MR CONDITIONAL ASPECTS OF THE DEVICE. ADDITIONAL FOLLOW-UP WITH THE USER WAS COMPLETED BY THE SALES REPRESENTATIVE ON (B)(4) 2009, AND THE USER INDICATED THAT THEY HAVE DONE SEVERAL CASES SINCE THE COMPLETION OF THE MRI SUITE AND HAVE NOT HAD ANY MORE INCIDENTS WITH THE DEVICE. NO ADDITIONAL ACTION IS WARRANTED OR PLANNED.

    Description of Event or Problem · 1

    THE PATIENT MONITOR MANUFACTURER RECEIVED A LETTER FROM THE CUSTOMER THAT STATED THE FOLLOWING: "THE INVIVO MONITOR MOUNTED ON THE INTERVENTIONAL TABLE PATIENT SLIDE IS MAGNETIC. IT HAS NO CAUTION OR WARNING SIGNS ON THE MONITOR ITSELF. WHEN THE CUSTOMER UNDOCKS THE TABLE, THE TABLE NEEDS TO MAKE A 90 DEGREE TURN TO EXIT THE OUTER DOUBLE DOORS. WHEN THE TABLE TURNS, IT TURNS TOWARD THE FRONT OF THE MAGNET AND THE PULL OF THE MAGNETIC FIELD FOR THE MONITOR IS FELT. IF THE CUSTOMER IS UNAWARE AND INATTENTIVE, THE TABLE COULD MOVE ON ITS OWN TOWARDS THE MAGNET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION 3160 MRI PATIENT MONITORING SYSTEM - FIXED MOUNT MWI INVIVO CORPORATION 3160-16

    Patients

    Seq Age Sex Outcome Treatment
    1