BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3802117 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13874
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 11, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE LEFT MONITOR WAS EVALUATED AND REPLACED THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR WAS INTERMITTENTLY NOT WORKING. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. 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
    679816 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1