BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2961629 · Received February 11, 2013

    Report

    Report Number
    1720753-2013-01643
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. ALL CONNECTORS IN THE WORKSTATION, MAINFRAME AND CAMERA WERE RESEATED AND TIGHTENED. THE SYSTEM WAS THEN FOND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE WENT DARK DURING A PROCEDURE. AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE CASE. THE SYSTEM WAS REPORTEDLY RENDERED UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60215 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1