BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 3802006 · Received February 4, 2014

    Report

    Report Number
    1720753-2014-01134
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 4, 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 REPAIR QUOTE WAS SENT TO THE CUSTOMER; HOWEVER, THEY HAVE NOT RESPONDED TO SET UP A TIME FOR REPAIR. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OF DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73757 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1