BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1930062 · Received December 2, 2010

    Report

    Report Number
    1720753-2010-04367
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 30, 2010
    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 SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM HAD AN OVERLOAD FAULT ERROR AND SHUT DOWN ON ITS OWN DURING A CASE. THE 9900 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. 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