BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3980185 · Received June 5, 2014

    Report

    Report Number
    1720753-2014-04755
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR WAS EVALUATED AND REPAIRED. 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 SYSTEM EXHIBITED 'IRIS POTENTIOMETER ERRORS' UPON SYSTEM START UP. THIS ERROR WILL PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330416 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1