BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVARIA

    MDR report key: 6554078 · Received May 9, 2017

    Report

    Report Number
    3005753836-2016-00003
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    February 7, 2014
    Report Date
    April 4, 2016
    Manufacturer
    SAVARIA CONCORD LIFTS INC
    Product Code
    PCE
    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 = (B)(4). AS OF REPORTING APRIL 1 2016 - (B)(4) 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: 02/18/2014. FOLLOW UP FOR WORK COMPLETION DATE: APRIL 2014, JULY 2014 , DECEMBER 2014, FEBRUARY 2015, APRIL 2015 - DEALERS REQUESTING NEW KITS WERE SENT: AUGUST 2015, DECEMBER 2015, FEBRUARY 2016, MARCH 2016.

    Description of Event or Problem · 1

    DURING NORMAL OPERATION, THE LIFT WHILE CARRYING A PASSENGER AND WHEELCHAIR IN THE DOWN DIRECTION CAME UNFASTENED FROM THE UPPER LIFTING TROLLEY AND LIFTING CABLE. THE CARRIAGE AND PLATFORM NOW RELEASED FROM THE CABLE SYSTEM SLID DOWN THE LENGTH OF STAIRS BEING GUIDED BY THE LOWER TROLLEY THAT REMAINED CONNECTED. THE PLATFORM HIT THE BOTTOM LANDING CAUSING THE RIDER TO BE THROWN FORWARD HITTING THEIR HEAD AGAINST THE WALL. IT WAS FOUND THAT THE 5 BOLTS THAT WERE HOLDING THE CARRIAGE TO THE UPPER TROLLEY WORKED LOOSE AND EVENTUALLY FAILED RELEASING THE PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335084 SAVARIA INCLINE PLATFORM LIFT PCE SAVARIA CONCORD LIFTS INC OMEGA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization