BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3231039 · Received July 12, 2013

    Report

    Report Number
    1720753-2013-08082
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SNUBBER BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT WORKING AND A LOSS OF X-RAY FUNCTIONALITY. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321740 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1