BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDICARE

    MDR report key: 22297451 · Received June 20, 2025

    Report

    Report Number
    3011268530-2025-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 10, 2025
    Manufacturer
    HANDICARE ACCESSIBILITY LTD.
    Product Code
    PCD
    UDI-DI
    05056233700069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE COMPLETED TRAVEL CYCLE BUT DID NOT SWIVEL DUE TO ACTIVATION OF SAFETY MECHANISM CAUSED BY ADVERSE TILT. RESOLVED BY PROVIDING SPACERS TO AMEND TILT. REPORT DELAYED PAST INITIAL SUBMITTING PERIOD AS WE DID NOT INITIALLY BELIEVE IT WAS REPORTABLE HOWEVER RECEIVED ADDITIONALLY INFORMATION INDICATING THAT IT IS.

    Description of Event or Problem · 0

    USER REPORTED THAT THEY COMPLETED TRAVEL ON LIFT HOWEVER SWIVEL DID NOT ENGAGE. UPON DISMOUNTING THE USER STATES, THEY ALMOST FELL HOWEVER CARER ASSISTED THEM. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669854 HANDICARE POWERED STAIRWAY CHAIR LIFT PCD HANDICARE ACCESSIBILITY LTD. 4000 05056233700069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female