BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2100417 · Received May 13, 2011

    Report

    Report Number
    1720753-2011-07326
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 13, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE X-RAY TUBE AND INSPECTED THE ESD KIT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE X-RAY TUBE WAS CRACKED DURING FLUOROSCOPIC X-RAY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1