BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3802130 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13875
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    October 21, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE WIRES IN THE CORD CAP WERE TIGHTENED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHORT IN THE POWER CORD INTERMITTENTLY PREVENTED THE SYSTEM FROM BOOTING UP. 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
    679797 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1