BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1840103 · Received September 15, 2010

    Report

    Report Number
    1720753-2010-03081
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 15, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT DURING A CASE THE VIDEO ON THE LEFT MONITOR HAD A VERTICAL SHIFT CAUSING DISTORTION TO THE IMAGE. THEY REBOOTED WITHIN THE CASE BUT WEREN'T ABLE TO RECOVER. 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