BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4142850 · Received September 30, 2014

    Report

    Report Number
    1720753-2014-08318
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE LEMO AND INTERCONNECT CABLE PIN CONNECTIONS WERE EVALUATED AND IDENTIFIED AS REQUIRING REPAIR. THE FACILITY BIOMEDICAL DEPARTMENT WAS SCHEDULED TO ADDRESS THE ISSUE AT A FUTURE DATE. NO CONCLUSION CAN BE DRAWN AS SYSTEM ANALYSIS OR REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CABLE CONNECTION. FURTHER INFORMATION WAS RECEIVED FROM THE SITE INDICATING THAT THE CONNECTION ISSUE RESULTED IN THE INABILITY TO VIEW THE FLUOROSCOPIC IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607231 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1