BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3980120 · Received July 2, 2014

    Report

    Report Number
    1720753-2014-05644
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. SYS CONNECTIONS AND POWER SUPPLIES WERE EVALUATED AND CONFIRMED TO BE OPERATING WITHIN SPECIFICATION. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER RPEORTED THAT THE SYSTEM APPEARED TO CONTINUOUSLY BEEP AFTER THE RELEASE OF THE EXPOSURE SWITCH. X-RAY WAS NOT BEING PRODUCED AND THIS EVEN IS CONSISTENT WITH A SYS LOCK UP. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388357 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1