BEUDAMED
    FDA Adverse Event Other Summary report: N

    3160 MRI PATIENT MONITOR

    MDR report key: 1604263 · Received February 3, 2010

    Report

    Report Number
    1051786-2010-00010
    Event Type
    Other
    Date Received
    February 3, 2010
    Report Date
    January 4, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER WAS ADVISED BY TECHNICAL SUPPORT THAT THEY NEED TO MAINTAIN THE PHLEBOSTATIC AXIS AND TO MAKE SURE THE TRANSDUCER IS AT THE SAME LEVEL AS THE HEART WHEN THE PT IS SLIDE INTO THE BORE OF THE MAGNET. THE USER REPORTED THAT THE DEVICE MFR DID NOT SUPPLY THEM WITH THE TRANSDUCER THAT WAS CAUSING THEM PROBLEMS. THE USER REPORTED THAT THEY HAVE ALSO USED A SECOND VENDOR'S TRANSDUCERS AND WERE NOT EXPERIENCING THIS SAME PROBLEM WITH THIS TRANSDUCER. THIS INFO INDICATES THAT THE REPORTED PROBLEM WAS WITH A TRANSDUCER NOT SUPPLIED BY THE DEVICE MFR. THE USER WAS GOING TO REPORT THE PROBLEM TO THE TRANSDUCER SUPPLIER AND WORK WITH THEM ON A SOLUTION. THE TWO TRANSDUCERS THAT THE USER FACILITY WAS UTILIZING ARE NOT LISTED IN THE INSTRUCTIONS FOR USE AS BEING RECOMMENDED FOR USE WITH THE DEVICE. ADDITIONALLY, THE INSTRUCTIONS FOR USE STATE: "USE ONLY APPROVED PRESSURE TRANSDUCERS AND CABLES, AS LISTED IN THE ACCESSORY SECTION." WE ARE NOT CONSIDERING THIS REPORT TO BE A MALFUNCTION OF THE DEVICE LISTED IN THIS REPORT SINCE IT WAS DETERMINED THAT THE PROBLEM WAS CAUSED BY A TRANSDUCER NOT SUPPLIED BY THE DEVICE MANUFACTURER. ALSO, THE TRANSDUCERS IN USE BY THE USER FACILITY ARE NOT RECOMMENDED FOR USE WITH THE DEVICE, AS INDICATED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE USER CLAIMED THAT THE IBP PARAMETER WAS GIVING A LOW READING WHEN THE PT IS MOVED INTO THE MRI BORE. THERE WAS NO ADVERSE PT IMPACT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1