BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS

    MDR report key: 1083246 · Received July 25, 2008

    Report

    Report Number
    MW5007805
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 25, 2008
    Manufacturer
    IMRIS, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABOUT 20 MINUTES INTO SURGERY, DOROS HEADFRAME OBSERVED TO HAVE LOOSENED WITH SOME ROTATION OF PT'S HEAD NOTED. RE-TIGHTENED DEVICE, AND TAPED IN PLACE. NO FURTHER PROBLEM WITH HEADFRAME. DEVICE TAKEN OUT OF SVC AND MFR ASKED TO HAVE IT BACK AND THEY WILL REPLACE. NO PT INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS DOROS HEAD FRAME HAW IMRIS, INC. 3033-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other