BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3244478 · Received July 17, 2013

    Report

    Report Number
    9680959-2013-01417
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED AND FOUND T OBE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INTERMITTENT PROBLEM WHERE THE SYSTEM WOULD NOT ALWAYS POWER UP, (INTERMITTENT NO BOOT). THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332926 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1