BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4180880 · Received October 10, 2014

    Report

    Report Number
    1720753-2014-08527
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 10, 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 ONSITE INVESTIGATION. THE PS1 WAS EVALUATED AND ADJUSTED. THE FFB PCB WAS RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED "X-RAY DISABLED ERRORS" AND SELF-REBOOTS RESULTING IN AN INTERMITTENT LOSS OF FLUOROSCOPIC FUNCTIONALITY. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. 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
    642981 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1