BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2896119 · Received December 10, 2012

    Report

    Report Number
    1720753-2012-10277
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 10, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE HIGH VOLTAGE CABLE NEEDED TO BE REPLACED, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT (LIVE) MONITOR WAS BLANK AND THAT THE SYSTEM HAD SOME COLLIMATOR ISSUES. THESE ISSUES CAUSED THE SYSTEM TO BE UNUSABLE DUE TO A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    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