BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3770105 · Received January 28, 2014

    Report

    Report Number
    1720753-2014-00947
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 28, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CHAIN ADJUSTER WAS EVALUATED AND FOUND TO BE HITTING THE DETENT CAM. THE STEERING MECHANISMS AND COMPONENTS WERE LUBRICATED AND THE LINK TO THE DETENT CAM WAS ADJUSTED ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE STEERING MECHANISM WAS STIFF AND DIFFICULT TO MANIPULATE. NO PATIENT OR USER INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61443 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1