BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2022294 · Received February 28, 2011

    Report

    Report Number
    1720753-2011-01768
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE LEFT MONITOR WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9800 SYSTEM LEFT MONITOR WAS DARK DURING CASE. THE SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1