BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3884219 · Received May 20, 2014

    Report

    Report Number
    1720753-2014-04341
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 20, 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 REP EVALUATED THE SYSTEM AND RECOMMENDED THE REPLACEMENT OF THE INTERCONNECT CABLE; HOWEVER, NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. 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
    299289 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1