BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WAY SIT TO STAND

    MDR report key: 10534975 · Received September 14, 2020

    Report

    Report Number
    MW5096612
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 11, 2020
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACTUATOR ARM END BROKE DURING LIFT, RESIDENT WAS LOWERED GENTLY TO THE FLOOR TO AVOID INJURY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997477 EZ WAY SIT TO STAND LIFT, PATIENT, NON-AC-POWERED FSA EZ WAY, INC. 800 EZ WAY STAND PREMIER 500LB W

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other