BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3902809 · Received May 9, 2014

    Report

    Report Number
    1720753-2014-04075
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 9, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN OVER THE PHONE INVESTIGATION AND PROVIDED A QUOTE TO THE CUSTOMER. THE CUSTOMER DECIDED TO NOT PROCEED WITH REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281766 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1