BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2971184 · Received February 1, 2013

    Report

    Report Number
    1720753-2013-01390
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CALIBRATION FILES WERE LOADED 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

    IT WAS REPORTED THE SYSTEM DISPLAYED AN IRIS POT ERROR AT BOOT UP AND THAT THE SYSTEM HAD LOSS X-RAY FUNCTIONALITY. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45370 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1