BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 1601143 · Received February 1, 2010

    Report

    Report Number
    1051786-2010-00008
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Report Date
    January 6, 2010
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS REPORT IS THE AC POWER ADAPTER/POWER CABLE USED IN CONJUNCTION WITH THE DEVICE' DISPLAY UNIT. THE DEVICE MFR HAS NOT VERIFIED THE FAILURE MODE AND WHETHER THIS POSSIBLY POSES A HEALTH RISK. THE DEVICE IN QUESTION IS CURRENTLY BEING EVALUATED BY THE VENDOR. UPON COMPLETION OF THE INVESTIGATION, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE USER CLAIMED THAT THE POWER ADAPTER GETS HOT DURING USE. THERE WAS NO REPORTED PT OR USER ADVERSE IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1