BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1933206 · Received November 10, 2010

    Report

    Report Number
    9680959-2010-00494
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 16, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A CIRCUIT BOARD IN THE IMAGE PROCESSING MODULE. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DISPLAYS A "LOW CAMERA VOLTAGE" ERROR MESSAGE AND WILL NOT PRODUCE X-RAYS OR IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1