BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED QXI

    MDR report key: 351203 · Received September 6, 2001

    Report

    Report Number
    2183289-2001-00005
    Event Type
    Malfunction
    Date Received
    September 6, 2001
    Date of Event
    August 10, 2001
    Report Date
    September 6, 2001
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE MOVED UP WITHOUT COMMAND WHILE A PATIENT WAS ON IT. THE TECHNOLOGIST NOTICED THE MOVEMENT AND HIT THE E-STOP. THE PATIENT DID NOT CONTACT THE GANTRY AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40421 LIGHTSPEED QXI COMPUTED TOMOGRAPHY JAK GE MEDICAL SYSTEMS 2180551 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA