BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPHANIX

    MDR report key: 4827777 · Received June 5, 2015

    Report

    Report Number
    3006972752-2015-00001
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Report Date
    June 2, 2015
    Manufacturer
    STEPHANIX
    Product Code
    JAA
    PMA / PMN Number
    K102529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONCLUDED THAT THE INSTALLATION OF SPRING WASHERS IMPROVES THE MANAGEMENT OF TENSION OF THE CARRIAGE TRAIN. AFFECTED UNITS ARE BEING CORRECTED IN THE FIELD AND THE CORRECTION HAS ALREADY BEEN IMPLEMENTED IN THE FACTORY.

    Description of Event or Problem · 1

    WE HAVE DETECTED A POTENTIAL RISK IN OUR D2RS DEVICES, THAT COULD LEAD TO THE SLIDING OF THE COLUMN SUPPORT CARRIAGE TO ITS END OF TRAVEL AND COULD HARM A PATIENT, A USER, OR A THIRD PARTY. THE MAIN RISK FACTOR OF THIS EVENT COULD BE AN EXCESSIVE TENSION OF THE COLUMN SUPPORT CARRIAGE DRIVE CHAIN ASSOCIATED WITH OTHER SIMULTANEOUS FACTORS WHICH MAKE THIS RISK REALLY UNLIKELY. ALTHOUGH THIS INCIDENT HAS NEVER OCCURRED, A SAFETY ACTION IS INITIATED IN ORDER TO COMPLETELY ELIMINATE THIS POTENTIAL RISK AND TO ENSURE THE SAFETY OF PATIENTS, USERS AND THIRD PARTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366466 STEPHANIX SYSTEM, X-RAY, FLUOROSCOPIC JAA STEPHANIX D2RS

    Patients

    Seq Age Sex Outcome Treatment
    1