BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2771764 · Received October 2, 2012

    Report

    Report Number
    1720753-2012-07824
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED. HOWEVER, THE POWER TO THE CONTROL PANEL PROCESSOR WAS DISCOVERED TO BE LOW AND THE RELATED CONTACTS AND CONNECTORS WERE CLEANED AND RESEATED. THE ALLEGED MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS DURING A PT PROCEDURE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1