BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCA POSITIONER

    MDR report key: 521326 · Received February 3, 2004

    Report

    Report Number
    9615767-2004-00002
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Date of Event
    November 30, 2003
    Report Date
    February 3, 2004
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN TECH PERFORMED A SYSTEM RESET, THE IMAGE INTENSIFIER (ON C-ARM) MOVED AT A FAST SPEED UNTIL IT CONTACTED THE MECHANICAL HARD STOP. THIS MOVEMENT IS NOT EXPECTED AT SYSTEM RESET. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCA POSITIONER DIAGNOSTIC X-RAY LCI GE MEDICAL SYSTEMS EUROPE 2168677 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA