BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2310727 · Received October 24, 2011

    Report

    Report Number
    1720753-2011-23170
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    October 12, 2011
    Report Date
    October 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND CLEANED AND RELUBRICATED THE HIGH VOLTAGE CABLE CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WOULD NOT DISPLAY AN IMAGE. NO PATIENT INJURY WAS REPORTED.

    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