BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3102152 · Received May 3, 2013

    Report

    Report Number
    1720753-2013-05670
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 3, 2013
    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 SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SVC CALL. THE SYS WAS TESTED ADN FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT INITIALIZE AND START UP, NOT BOOT. THERE IS NO REPORT OF INJURY OF DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194558 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1