BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3201390 · Received June 26, 2013

    Report

    Report Number
    1720753-2013-07621
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SPOKE TO THE ONLINE ENGINE AND REPORTED THAT THE ISSUE DID NOT OCCUR AGAIN, AND THEY WOULD CALL BACK IF IT RECURRED. THE CUSTOMER NEVER CALLED BACK, AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM MONITOR WAS INTERMITTENTLY GOING BLACK. THIS RESULTED IN THE LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290971 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1