BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3791970 · Received January 14, 2014

    Report

    Report Number
    1720753-2014-00491
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 10, 2013
    Report Date
    January 14, 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 REP PERFORMED AN ONSITE INVESTIGATION. THE VIDEO CONTROLLER PCB AND IMAGE PROCESSOR PCB CONNECTIONS WERE EVALUATED AND RESEATED. THE ASSOCIATED POTENTIOMETER WAS ALSO CALIBRATED TO THE OPTIMAL POSITION. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUOROSCOPIC IMAGE WAS DEGRADED AND WAVY. FURTHER INFO WAS RECEIVED FROM THE FSE WHICH FOUND THAT A USABLE IMAGE WAS UNABLE TO BE VIEWED. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36071 9600 FLUOROSCOIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1