BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION PRECESS (3160 SERIES) MRI PATIENT MONITORING SYSTEM

    MDR report key: 2172460 · Received June 24, 2011

    Report

    Report Number
    1051786-2011-00005
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS AN ALLEGATION THAT THE DEVICE WAS DRAWN TO THE MAGNET AND THAT THE USER DID NOT VIOLATE THE DEVICE'S MR CONDITIONAL LABELING. THEREFORE, WE ARE REPORTING THIS OCCURRENCE. ACCORDING TO THE USER, GENERAL ELECTRIC (MAKER OF THE MRI MAGNET) VISITED THE USER FACILITY AND CONFIRMED THE GAUSS READING TO BE FROM 50 GAUSS TO 400 GAUSS AT THE REPORTED LOCATION WHERE THE DEVICE BEGAN TO ROLL TOWARDS THE MAGNET. THE DEVICE MFR VISITED THE USER FACILITY IN ORDER TO EVALUATE THE REPORTED EVENT. A HAND-HELD MAGNET WAS RUN OVER THE DEVICE TO DETERMINE IF THERE WAS UNEXPECTED MAGNETIC MATERIAL LOCATED ON OR IN THE DEVICE, BUT NO UNEXPECTED MAGNETIC MATERIAL WAS FOUND. THE DEVICE MFR CONFIRMED THE FOLLOWING WITH RESPECT TO THE BEHAVIOR OF THE DEVICE AT VARIOUS DISTANCES FROM THE MAGNET INVOLVED IN THIS INCIDENT. NOTE: FOR REFERENCE, THE DEVICE'S INSTRUCTIONS FOR USE (IFU) STATES THAT THE DEVICE MUST NEVER BE PLACED CLOSER THAN 3 FEET FROM THE MR SYS, WITH THE WHEELS LOCKED WHEN THE DEVICE IS LEFT UNATTENDED. AT 16 INCHES (1.33 FEET) AND 33 INCHES (2.75 FEET) FROM THE MAGNET, THE DEVICE STARTED TO ROLL TOWARDS THE MAGNET WHEN THE DEVICE'S WHEELS WERE NOT LOCKED. HOWEVER, IF THE DEVICE'S WHEELS WERE LOCKED, THE DEVICE DID NOT ROLL TOWARDS THE MAGNET. AT 3 FEET FROM THE MAGNET (MEETS LABELING), THE DEVICE DID NOT ROLL TOWARDS THE MAGNET IF THE DEVICE'S WHEELS WERE LOCKED. AT 4 FEET FROM THE MAGNET (MEETS LABELING), THE DEVICE DID NOT ROLL TOWARDS THE MAGNET, EVEN IF THE DEVICE'S WHEELS WERE UNLOCKED. DURING THIS VISIT, IT WAS ALSO DISCOVERED THAT THE USER'S INITIAL CLAIM THAT THE INCIDENT OCCURRED WHEN THE DEVICE WAS "5 - 6 FEET" FROM THE MAGNET WAS ERRONEOUS. THE TECH'S INITIAL ESTIMATE OF HOW FAR THE DEVICE WAS FROM THE MAGNET WAS A GUESSTIMATE BASED ON HER "ARM'S LENGTH". ALTHOUGH, IT WAS NOT DETERMINED EXACTLY WHERE THE DEVICE WAS WHEN THE INCIDENT OCCURRED, THE TESTING CONDUCTED ON-SITE BY THE DEVICE MFR CONFIRMS THAT THE DEVICE BEHAVES AS EXPECTED WHEN THE IFU IS FOLLOWED. THE IFU CONTAINS NUMEROUS WARNINGS AND PRECAUTIONS REGARDING THE DISTANCE THE DEVICE MUST BE KEPT FROM THE MRI MAGNET TO ENSURE SAFE AND CONTINUED OPERATION. ADDITIONALLY, THE IFU CONTAINS NUMEROUS REFERENCES TO THE NEED TO LOCK THE DEVICE'S WHEELS WHEN THE DEVICE IS LEFT UNATTENDED. ADDITIONALLY, THE DEVICE ITSELF HAS SEVERAL LABELS THAT DEPICT THE PROPER DISTANCE THE DEVICE SHOULD REMAIN FROM THE MRI MAGNET. THESE LABELS ALSO DEPICT THE NEED FOR THE USER TO LOCK THE DEVICE'S WHEELS WHEN THE DEVICE IS LEFT UNATTENDED. THE DEVICE MFR CONFIRMED THE PRESENCE OF THESE LABELS ON THE USER'S DEVICE. AS CORRECTIVE ACTION, THE USER REQUESTED AN ELECTRONIC COPY OF THE IFU, WHICH WAS PROVIDED BY THE DEVICE MFR. THE USER CLAIMED THAT HE WAS GOING TO USE THE INFO IN THE IFU TO CONDUCT REFRESHER TRAINING ON MR SAFETY WITH THE USERS OF THE DEVICE. THE USER DID NOT REQUEST THE DEVICE MFR'S ASSISTANCE WITH THIS TRAINING. ADDITIONALLY, THE DEVICE MFR PROVIDED THE USER WITH THE PART NECESSARY TO FIX THE DEVICE'S REPORTED NIBP PROBLEM, WHICH OCCURRED AS A RESULT OF THIS INCIDENT. THE DEVICE MFR FOLLOWED UP WITH THE USER AND CONFIRMED THAT THE NIBP PARAMETER WAS WORKING PROPERLY FOLLOWING REPLACEMENT OF THIS PART. WE ARE NOT CONSIDERING THE REPORTED NIBP PROBLEM TO BE A MALFUNCTION OF THE DEVICE SINCE THE PROBLEM OCCURRED AS A DIRECT RESULT OF THE USER NOT FOLLOWING THE INSTRUCTIONS FOR USE. SINCE THE INVESTIGATION SHOWS THAT THERE WAS NO MALFUNCTION OF THE DEVICE, NO FURTHER PRODUCT INVESTIGATION IS WARRANTED. BASED ON THE REVIEW OF THE DEVICE'S OVERALL LABELING AND IFU, IT WAS DETERMINED THAT THERE IS NOT A DEFICIENCY IN THE WARNINGS RELATED TO THE DISTANCE THE DEVICE MUST BE KEPT FROM THE MRI MAGNET AND THE NEED TO LOCK THE DEVICE'S WHEELS WHEN THE DEVICE IS LEFT UNATTENDED. NO ADD'L ACTIONS ARE WARRANTED.

    Description of Event or Problem · 1

    THE USER STATED THAT A TECH WAS BRINGING THE DEVICE INTO THE MRI SUITE. WHEN THE TECH LET GO OF THE DEVICE, IT STARTED ROLLING AND ATTACHED TO THE MAGNET. THE USER REPORTED THAT THE DEVICE WAS 5 - 6 FEET FROM THE MAGNET AND AT THE 200 - 400 GAUSS LINE (ACCORDING TO THE USER FACILITY'S FIELD STRENGTH MAP). THE USER STATED THAT THE DEVICE'S WHEELS WERE NOT LOCKED WHEN THE INCIDENT OCCURRED. THE USER CLAIMED THAT THERE WAS A PT PRESENT WHEN THE INCIDENT OCCURRED, BUT THE PT WAS NOT IN THE MRI BORE. THERE WAS NO REPORTED INJURY TO THE PT, USERS OR HOSP STAFF. THE USER ALSO REPORTED THAT THE DEVICE'S NIBP PARAMETER WAS NOT FUNCTIONING FOLLOWING THIS INCIDENT.

    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