BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3111897 · Received May 7, 2013

    Report

    Report Number
    1720753-2013-05752
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER CORD, HARD DRIVE, AND CINE HARD DRIVE WERE REPLACED DURING THE SERVICE CALL. THIS SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SYSTEM HAD MULTIPLE BOOT ERRORS IN THE LOGS, INDICATING POWER INTERRUPTIONS TO HARD DRIVES AND WOULD NOT BOOT UP. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199932 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1