BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3060510 · Received April 10, 2013

    Report

    Report Number
    1720753-2013-04801
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND A MEMORY CARD NEEDED TO BE REPLACED, BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT PRODUCE X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152681 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1