BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE RELIANT 600

    MDR report key: 8637054 · Received May 22, 2019

    Report

    Report Number
    8637054
    Event Type
    Death
    Date Received
    May 22, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 20, 2019
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF INVACARE 600 LIFE WHILE TRANSFERRING PT. LIFT ARM WITH SLING DETACHED FROM UNIT FOLLOWED BY PT FALL TO THE GROUND. INITIAL MEDICAL IMAGING AND PHYSICAL EXAM DID NOT REVEAL ANY FRACTURES OR VISIBLE INJURY. PT EXPIRED 4 HOURS AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425458 INVACARE RELIANT 600 INVACARE 600 FSA INVACARE CORPORATION RPL600-2

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death