BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3201397 · Received June 26, 2013

    Report

    Report Number
    1720753-2013-07618
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 18, 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 CALLED AND REQUESTED THAT THE FIELD SERVICE REP ORDER AND DELIVER A GENERATOR INTERFACE BOARD TO REPAIR THE SYSTEM. THE BOARD WAS DELIVERED AS REQUESTED. NO FURTHER REPAIR INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. NO PT WAS INVOLVED IN THIS EVENT. THERE IS NO REPORT OF OT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290554 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1