BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3201444 · Received June 26, 2013

    Report

    Report Number
    1720753-2013-07595
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE TEMPERATURE SENSOR WAS REPLACED 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

    THE CUSTOMER REPORTED THE SYSTEM HAD A BAD X-RAY SENSOR DETECTED ERROR, THEN POPPED TWICE AND SHUT OFF AND WAS UNUSABLE. THERE ARE NO REPORTS OF PT I INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290373 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1