BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4142917 · Received September 12, 2014

    Report

    Report Number
    1720753-2014-07864
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 12, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE LEMO CONNECTOR WAS EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM GENERATED FLUOROSCOPY X-RAY WITHOUT COMMAND. THERE WAS NO INCIDENCE OF AN INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS OCCURED WITH A PATIENT INVOLVEMENT AND THEREFORE MAY HAVE RESULTED IN ACCIDENTAL RADIATION OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565405 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1