BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3792138 · Received January 8, 2014

    Report

    Report Number
    1720753-2014-00262
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 17, 2013
    Report Date
    January 8, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION INCLUDED INSPECTION AND OPTIMIZATION OF THE 5 VDC POWER SUPPLY, HOWEVER NO DEFINITIVE CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS INTERMITTENTLY BLANK. THIS ISSUE WILL EFFECTIVELY ELIMINATE THE ABILITY TO VIEW A REAL TIME IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12962 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1