BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3151359 · Received May 30, 2013

    Report

    Report Number
    1720753-2013-06571
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FOOT SWITCH WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AD FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM COULD NOT MAKE FLUOROSCOPIC IMAGES BECAUSE THERE WAS NO HAND SWITCH AND THE FOOTSWITCH WAS INOPERATIVE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237783 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1