BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3915848 · Received June 12, 2014

    Report

    Report Number
    1720753-2014-05013
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 12, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CONTACTS ON THE 5V POWER SUPPLY WERE CLEANED AND RESEATED, AND THE VOLTAGE ON THE POWER SUPPLY PS1 WAS ADJUSTED TO 5.05V FOR OPTIMAL PERFORMANCE. 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 LOCKED UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH TO EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347098 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1