BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2100382 · Received May 13, 2011

    Report

    Report Number
    1720753-2011-07324
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 13, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE KV WAS ADJUSTED BACK INTO TOLERANCE. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PHYSICIST DISCREPANCY, THE KV WAS OUT OF TOLERANCE. 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