BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4203052 · Received September 18, 2014

    Report

    Report Number
    1720753-2014-07992
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEM (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE VIDEO LINE OF THE INTERCONNECT CABLE WAS EVALUATED AND REPAIRED. 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. FURTHER INFORMATION WAS RECEIVED FROM THE FIELD SERVICE ENGINEER INDICATING THAT THIS ERROR RESULTED IN A SYSTEM LOCKUP. THERE IS NO REPORT OF A PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578894 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEM (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1