BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3871823 · Received April 17, 2014

    Report

    Report Number
    1720753-2014-03402
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE COLLIMATOR CIRCUIT FUSE AND FUSE HOLDER WERE 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 THE FLUOROSCOPIC IMAGE WAS REDUCED TO A SINGLE LINE EFFECTIVELY ELIMINATING THE ABILITY TO VIEW A USABLE IMAGE. NO PT DEATH OR INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236555 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1