BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1885293 · Received October 25, 2010

    Report

    Report Number
    1720753-2010-03745
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 10, 2010
    Report Date
    October 25, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE DOSE RATE WAS ADJUSTED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM DOSE RATE WAS TOO HIGH. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1