BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3240980 · Received July 18, 2013

    Report

    Report Number
    1720753-2013-08307
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S COLLIMATOR WOULD CLOSE DOWN ALL THE WAY AT BOOT UP OR WHEN A NEW PATIENT WAS ENTERED INTO THE SYSTEM. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335255 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1