BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2062057 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03282
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE SYSTEM WAS REPLACED WITH ANOTHER C-ARM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR WOULD PRODUCE A BLURRY IMAGE ON THE 9800 SYSTEM. NO PT 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