BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3010922 · Received March 14, 2013

    Report

    Report Number
    1720753-2013-03786
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERLOCK FAILURE ERROR MESSAGE. THIS ERROR CAUSES THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108386 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1