BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3834487 · Received March 17, 2014

    Report

    Report Number
    1720753-2014-02412
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 3, 2014
    Report Date
    March 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR AND POWER SWITCH WERE EVALUATED AND REPLACED, AND THE COLLIMATOR WAS ADJUSTED. 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 HAD A COLLIMATOR POTENTIOMETER ERROR. THE FIELD ENGINEER NOTED THAT THE SYSTEM WOULD INTERMITTENTLY NOT BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156908 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1