BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX EXTRA-WIDE CLINICAL CARE RECLINER

    MDR report key: 5856184 · Received August 9, 2016

    Report

    Report Number
    5856184
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 1, 2016
    Report Date
    August 5, 2016
    Manufacturer
    HIGH SPOT HEALTH TECHNOLOGY CO., LTD.
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CASTERS (WHEEL) LOCKING MECHANISM BREAK EASILY DUE TO BEING PLASTIC. ONCE THESE BREAK THE CHAIR IS UNABLE TO BE IN A STATIONARY MODE AND WILL MOVE DURING ATTEMPTS TO SIT OR RISE INTO/FROM THE CHAIR POSING A FALL RISK. ADDITIONALLY, THE FOOT REST IS ONLY ABLE TO FULLY BE RETRACTED (PARKED) IF THE WHEELS ARE ALIGNED PERFECTLY FORWARD. NEED TO HAVE THE FOOTREST FULLY "PARKED" PRIOR TO ENTRY/EXIT OF THE CHAIR FOR PATIENT SAFETY OR PATIENTS HAVE BEEN KNOWN TO CUT THEIR ANKLES, ALSO CAUSES STAFF TO USE FORCE LENDING TO STAFF INJURY, PATIENT INJURY AND TEARING OF THE FOOTREST FABRIC REQUIRING REPEATED REPAIR. RECLINING IS WEIGHT BASED AND SHIFTING IN CHAIR CAN CAUSE THE CHAIR TO UNEXPECTEDLY SNAP INTO UPRIGHT POSITION, STAFF ARE USING OTHER CHAIRS TO PROP THE FOOT REST ON TO ASSURE THAT THIS CANNOT HAPPEN TO AVOID PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510304 LUMEX EXTRA-WIDE CLINICAL CARE RECLINER CHAIR, ADJUSTABLE, MECHANICAL INM HIGH SPOT HEALTH TECHNOLOGY CO., LTD. 587W-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other