BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3874577 · Received April 22, 2014

    Report

    Report Number
    1720753-2014-03532
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS DEGRADED WITH HALO EFFECTS WHEN THE SYSTEM WAS MOVED TO A LATERAL POSITION EFFECTIVELY ELIMINATING THE ABILITY TO VIEW A USABLE IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243772 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1