BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3770104 · Received January 28, 2014

    Report

    Report Number
    1720753-2014-00950
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 28, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE FFB PCB ASSEMBLY WAS CLEANED AND RESEATED. ASSOCIATED POWER SUPPLIES WERE ALSO EVALUATED AND CONFIRMED TO BE OPERATING WITHIN PRE-DETERMINED SPECIFICATIONS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXPERIENCED AN UN-COMMANDED COLLIMATOR CONE DOWN. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61449 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1