BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1973614 · Received January 19, 2011

    Report

    Report Number
    1720753-2011-00373
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    September 14, 2010
    Report Date
    January 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE PRINTER CIRCUIT BOARD AND A CABLE WERE RESEATED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS FAILED TO PRODUCE FLUOROSCOPIC X-RAY. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1