BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAIRFRIEND

    MDR report key: 6554099 · Received May 9, 2017

    Report

    Report Number
    3005753836-2016-00002
    Event Type
    Malfunction
    Date Received
    May 9, 2017
    Date of Event
    February 24, 2015
    Report Date
    March 28, 2016
    Manufacturer
    SAVARIA CONCORD LIFTS INC
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TOTAL UNITS EFFECTED IN THE UNITED STATES 119. AS OF REPORTING APRIL 1 2016 - 44 UNITS REMAIN NOT CORRECTED. THE FOLLOWING DATES ARE CONTACTS WITH DEALERS BY PHONE AND/OR EMAIL TO ENFORCE THE REQUIREMENT TO CORRECT THE WELDED PART. INITIAL PARTS ORDER AND SHIPMENT DATE. FEBRUARY 25TH 2015, FEBRUARY 26TH 2015 ,FEBRUARY 27TH 2015. FOLLOW UP FOR WORK COMPLETION DATE. ON MAY 2015 - INSURE RECEIPT AND UNDERSTANDING OF CORRECTION AUGUST 2015 - FOLLOW UP NON COMPLETED UNITS. ON SEPTEMBER - 2015 FOLLOW UP NON COMPLETED UNITS. DECEMBER - 2015 FOLLOW UP NON COMPLETED UNITS. SALES DEPARTMENT FOLLOWING UP ON INDIVIDUAL BASIS.

    Description of Event or Problem · 1

    DURING OPERATION IT WAS FOUND THAT SOME OF THE SEAT POST WELDS WERE NOT PROPERLY DONE AND THE WELD WOULD CRACK CAUSING THE SEAT TO TILT. ONCE TILTED THE SEAT IS UNABLE TO SWIVEL AND IF NOT ADDRESSED THE SEAT POST WELD WOULD CONTINUE TO CRACK EVENTUALLY CORNING COMPLETELY SEPARATED THERE IS THE POTENTIAL FOR THE USER TO FALL POSSIBLY CAUSING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337185 STAIRFRIEND CURVED STIAR CHAIR LIFT PCD SAVARIA CONCORD LIFTS INC CSL 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention