BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3113243 · Received May 8, 2013

    Report

    Report Number
    1720753-2013-05843
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 8, 2013
    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 SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HEATER BOARDS WERE REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS DISPLAYED HEATER ERRORS AND WOULD NOT PERFORM FLUOROSCOPY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202339 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1