BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3962806 · Received June 23, 2014

    Report

    Report Number
    1720753-2014-05303
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GPOS PCB WAS EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATION FILES WERE RELOADED. 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 SYSTEM ONLY BOOTED TO 5 ARROWS (NO BOOT). THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THIS COULD CAUSE THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366085 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1