BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2153521 · Received June 21, 2011

    Report

    Report Number
    1720753-2011-08366
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND THE LEFT MONITOR WAS TO BE REPLACED IN ANOTHER CASE. IT IS ANTICIPATED THAT REPLACEMENT OF THIS PART WILL RESTORE THE SYSTEM TO ITS INTENDED USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S LEFT MONITOR WOULD NOT WORK OUTSIDE OF A PROCEDURE. 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