BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX RECLINER X WIDE FR587W

    MDR report key: 5093880 · Received September 22, 2015

    Report

    Report Number
    5093880
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 16, 2015
    Manufacturer
    HIGH SPOT HEALTH TECHNOLOGY CO., LTD.
    Product Code
    BYN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECLINER CHAIRS MADE SPECIFICALLY FOR HOSPITAL USE FOR PROPER PATIENT POSITIONING CONTINUE TO TEAR ON THE FOOT REST DUE TO DESIGN AND CATCHING ON THE WHEEL BASE. THIS TEAR BECOMES AN INFECTION RISK AND REQUIRES CONSTANT REPLACEMENT OF FABRIC TO ASSURE PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624127 LUMEX RECLINER X WIDE FR587W CHAIR, SURGICAL, AC-POWERED BYN HIGH SPOT HEALTH TECHNOLOGY CO., LTD. 2867FR587W

    Patients

    Seq Age Sex Outcome Treatment
    1