BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2210543 · Received August 8, 2011

    Report

    Report Number
    1720753-2011-20822
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE INDICATING THE IRIS NEEDED TO BE CALIBRATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1