BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2023088 · Received February 24, 2011

    Report

    Report Number
    1720753-2011-01669
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 6800 SYSTEM HAD AN INTERMITTENT X-RAY ON ERROR DURING A CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1