BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1376377 · Received February 27, 2009

    Report

    Report Number
    1720753-2009-01772
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 27, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP PERFORMED A SBC KIT THEN REPLACED THE CPU, DISPLAY ADAPTER AND GIB. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BOTH MONITORS WERE BLACK AND IMAGE ARTIFACTS. 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 INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1