BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3792120 · Received January 8, 2014

    Report

    Report Number
    1720753-2014-00288
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 12, 2013
    Report Date
    January 8, 2014
    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 REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE WORKSTATION HANDLE WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOLT HOLDING THE REAR OF THE HANDLE BROKE OR WAS SHEARED FLUSH WITH THE END OF THE HANDLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12476 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1