BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3963050 · Received June 23, 2014

    Report

    Report Number
    1720753-2014-05327
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPAIRED DURING THE SERVICE CALL. 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 VIDEO IMAGE WAS LOST WHEN THE C-ARM WAS ROTATED. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNSTABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366101 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1