BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1110003 · Received August 14, 2008

    Report

    Report Number
    1720753-2008-23918
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 23, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCHSCREEN WAS NOT WORKING, THE IMAGE DID NOT TRANSFER TO PACS, THE IMAGES SAVED UNDER DIFFERENT PT NAMES. ALSO, THE SYSTEM WAS SLOW WITH PROCESSING. A PT WAS INVOLVED, BUT NOT INJURED.

    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