BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3874643 · Received April 24, 2014

    Report

    Report Number
    1720753-2014-03636
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY WAS EVALUATED, REPLACED AND THEN CALIBRATED TO THE OPTIMAL OPERATING VOLTAGE. 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. AS A RESULT THE SYSTEM INTERMITTENTLY FAILED TO ALLOW FLUOROSCOPIC EXPOSURES AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248384 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1