BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 1593836 · Received January 27, 2010

    Report

    Report Number
    1051786-2010-00007
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Report Date
    August 5, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K040915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE USER FIRST CALLED THE DEVICE MANUFACTURER, THEY REPORTED THAT THE DEVICE'S PAPER CAUGHT ON FIRE, AND THEY WERE GETTING A FAULT ERROR MESSAGE WITH THE PRINTER. WHEN TRANSFERRED TO TECHNICAL SUPPORT, THE USER REPORTED THAT THE DEVICE WILL NOT POWER UP. THE USER WAS ADVISED THAT THE DEVICE SHOULD BE RETURNED TO THE DEVICE MANUFACTURER FOR EVALUATION AND REPAIR. THE USER WAS ALSO PROVIDED WITH THE PART NUMBER OF THE DEVICE'S POWER SUPPLY BOARD AS WELL AS THE PRINTER. TO DATE, THE USER HAS NOT ARRANGED FOR EVALUATION AND REPAIR OF THE DEVICE. ADDITIONALLY, THE USER HAS NOT ORDERED ANY OF THE PARTS NECESSARY TO PERFORM A REPAIR THEMSELVES. THE DEVICE MANUFACTURER HAS CALLED THE USER TO FOLLOW UP ON THE REPORTED INCIDENT, BUT THE USER HAS NOT RETURNED ANY OF THE DEVICE MANUFACTURER'S CALLS. AS A RESULT, THE DEVICE MANUFACTURER HAS NOT BEEN ABLE TO VERIFY WITH THE USER WHETHER OR NOT AN ACTUAL FIRE OCCURRED. IT CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION IF THE REPORTED PROBLEM WAS DUE TO A COMPONENT FAILURE OR IF ANY PART REPLACEMENT OR ANY OTHER ACTION WAS NEEDED TO RESTORE EXPECTED FUNCTION. NO ADDITIONAL ACTIONS ARE PLANNED BY THE DEVICE MANUFACTURER AT THIS TIME. THE PRINTED CIRCUIT BOARDS IN THIS DEVICE BEAR THE UL MARK OF CONFORMITY TO UL94. IN ORDER TO BEAR THAT MARK, THE BOARDS MUST HAVE A FLAMMABILITY RATING OF A LEAST UL94V-2. ADDITIONALLY, THIS DEVICE HAS A METAL ENCLOSURE, WHICH MEANS THAT IT IS NOT REQUIRED TO HAVE A FLAMMABILITY RATING. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY WHICH IMPACTS THIS REPORT OR IF THE DEVICE IS MADE AVAILABLE BY THE USER FOR EVALUATION BY THE DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE DEVICE'S PRINTER PAPER CAUGHT ON FIRE, THAT THEY WERE GETTING A FAULT ERROR MESSAGE WITH THE PRINTER AND THAT THE DEVICE WILL NOT POWER UP. THERE WAS NOT PATIENT INVOLVED IN THIS REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION MAGNITUDE MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3155MVS

    Patients

    Seq Age Sex Outcome Treatment
    1