BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1852049 · Received September 28, 2010

    Report

    Report Number
    1720753-2010-03235
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 28, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE PS3 POWER SUPPLY WAS ADJUSTED. THE SYSTEM INTERFACE BOARD, SINGLE BOARD COMPUTER, HARD DRIVE, AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2800 SYSTEM HAD THE COLLIMATOR CLOSE DOWN DURING A CASE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1