BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3172164 · Received June 11, 2013

    Report

    Report Number
    1720753-2013-06952
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND CLEANED, LUBRICATED, AND RESEATED THE HIGH VOLTAGE CANDLESTICK CONNECTORS, AND RESEATED CIRCUIT BOARDS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUORO WAS UNAVAILABLE DUE TO A COMMUNICATION PROBLEM FROM WORKSTATION TO C-ARM. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SE THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264137 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1