BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2896288 · Received December 5, 2012

    Report

    Report Number
    1720753-2012-10130
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 16, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE DARK. THE FIELD ENGINEER CONFIRMED THAT THE IMAGES WERE BLACK AND UNUSABLE. THERE IS NO REPORT OF PT INJURY.

    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