BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3113219 · Received May 8, 2013

    Report

    Report Number
    9680959-2013-00923
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE WAS INSTALLED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYS WOULD NOT ACCEPT THE PASSWORD AND WOULD NOT BOOT UP. THIS ISSUE WAS NOT DUE TO THE CUSTOMER UNABLE TO ENTER A PASSWORD, RATHER IT WAS DUE TO THE SYS'S SOFTWARE. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200192 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1