BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1852211 · Received September 29, 2010

    Report

    Report Number
    9617766-2010-00574
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    July 2, 2008
    Report Date
    September 29, 2010
    Manufacturer
    GE MED. SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 89800 SYSTEM WOULD NOT DISPLAY IMAGE ON THE LEFT MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MED. SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1