BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL HEAD GENESYS

    MDR report key: 375581 · Received February 1, 2002

    Report

    Report Number
    2916556-2002-00006
    Event Type
    Malfunction
    Date Received
    February 1, 2002
    Date of Event
    January 24, 2002
    Report Date
    January 30, 2002
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT DURING A COLLIMATOR EXCHANGE, THE COLLIMATOR EXCHANGE STAND DID NOT LOCK IN PLACE PROPERLY. THIS RESULTED IN THE COLLIMATOR EXCHANGE STAND'S FRONT LEGS TO SLIDE OFF OF THE GANTRY WHILE THE COLLIMATOR WAS RESTING ON IT. THERE WERE NO INJURIES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL HEAD GENESYS NUCLEAR MEDICINE EQUIPMENT IXY ADAC LABORATORIES 2144-3000B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *