BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PET ADVANCE GANTRY

    MDR report key: 284748 · Received June 29, 2000

    Report

    Report Number
    2126677-2000-00007
    Event Type
    Malfunction
    Date Received
    June 29, 2000
    Date of Event
    May 11, 2000
    Report Date
    June 29, 2000
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IYY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURING DISCOVERED A MISSING LOCK NUT FROM THE TILT MECHANISM OF THE PET ADVANCE GANTRY ON SOME SYSTEMS. THIS COULD POTENTIALLY LEAD TO FAILURE OF THE TILT MECHANISM, WHICH IN SOME GANTRY ORIENTATIONS MIGHT RESULT IN UNWANTED TILT OF THE GANTRY TOWARD THE PT, POSSIBLY RESULTING IN INJURY. THERE HAVE BEEN NO REPORTS OF INJURY ASSOCIATED WITH THIS INTERNAL FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PET ADVANCE GANTRY NUCLEAR MEDICINE IYY GE MEDICAL SYSTEMS 46-311001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA