BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX POWERED BARIATRIC RECLINER

    MDR report key: 17594849 · Received August 21, 2023

    Report

    Report Number
    MW5144808
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 16, 2023
    Report Date
    August 17, 2023
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHAIRS USED IN DIALYSIS (LUMEX POWERED BARIATRIC RECLINER, PRODUCT #FR588W8628, MODEL # FR588W8628, PURCHASED (B)(6) 2020) UNEXPECTEDLY RELEASE AND FALL BACK. VENDOR REPLACED ACTUATORS IN ALL CHAIRS IN (B)(6) 2022. SINCE THAT TIME, HAVE HAD TWO EVENTS WITH THE SAME ISSUE: ONE PATIENT WAS STATIONARY WHEN THE CHAIR RELEASED AND FELL FLAT; THE SECOND EVENT, THE PATIENT WAS IN THE PROCESS OF RECLINING BACK. NO HARM TO PATIENTS ON REPORTED EVENTS. BROKEN CHAIRS REMOVED FROM SERVICE. CHAIRS HAVE ALSO BROKEN WHEN BEING MOVED. ONE IDENTIFIED CHAIR HAS FAILED SINCE INITIAL REPAIR IN (B)(6) 2022. VENDOR ON-SITE (B)(6) 2023 TO ASSESS 4 ADDITIONAL MALFUNCTIONING CHAIRS (REPLACED CASTER ON ONE CHAIR AND REPLACE THE OTHER 3 CHAIRS). REFERENCE REPORTS: MW5144805, MW5144806, MW5144807, MW5144809.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035626 LUMEX POWERED BARIATRIC RECLINER CHAIR, WITH CASTERS INM GF HEALTH PRODUCTS, INC. FR588W8628

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male