BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX DELUXE CLINICAL CARE RECLINER WITH DROP ARMS

    MDR report key: 4336581 · Received December 16, 2014

    Report

    Report Number
    4336581
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL ORDERED 9 LUMEX RECLINER CHAIRS IN JANUARY 2014. IN AUGUST 2014 THE STEERING CASTERS BEGAN SHIFTING AND WOBBLING WHILE PATIENTS WERE BEING MOVED IN THE CHAIRS. EVENTUALLY, SOME OF THE CASTERS BEGAN FALLING OFF. IN AT LEAST ONE CASE THERE WAS A PATIENT IN THE CHAIR, THOUGH NO INJURY. ALSO THE BRAKES ON THE CHAIRS ARE MADE OF PLASTIC. WHEN THE NURSE TRIED TO SET THE BRAKE ON ONE CHAIR, THE PLASTIC BRAKE BROKE. THE WEIGHT LIMIT ON THESE CHAIRS IS 350 LBS. CURRENTLY, THERE ARE FIVE CHAIRS THAT ARE NOT USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823902 LUMEX DELUXE CLINICAL CARE RECLINER WITH DROP ARMS CHAIR, WITH CASTERS INM GF HEALTH PRODUCTS, INC. * *
    823903 LUMEX DELUXE CLINICAL CARE RECLINER WITH DROP ARMS CHAIR, WITH CASTERS INM GF HEALTH PRODUCTS, INC. * *
    823904 LUMEX DELUXE CLINICAL CARE RECLINER WITH DROP ARMS CHAIR, WITH CASTERS INM GF HEALTH PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *