BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3192226 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07416
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD WAS REPLACED, THE SYSTEM SOFTWARE WAS RELOADED, AND THE COLLIMATOR WAS RECALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COLLIMATOR WAS INTERMITTENTLY CLOSING. THIS WILL RENDER THE SYSTEM INOPERABLE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280299 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1