BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4152367 · Received October 3, 2014

    Report

    Report Number
    1720753-2014-08401
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE AND POWER CORD WERE EVALUATED AND REPLACED. THE SYSTEMS INTERFACE PCB WAS ALSO RESEATED DURING THE SERVICE EVENT. 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 THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR CAUSED THE SYSTEM TO AUTOMATICALLY REBOOT ITSELF RESULTING IN INTERMITTENT FUNCTIONALITY. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617541 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1