BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDICARE

    MDR report key: 10123568 · Received June 5, 2020

    Report

    Report Number
    3013423626-2020-00010
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    May 13, 2020
    Report Date
    October 15, 2020
    Manufacturer
    HANDICARE STAIRLIFTS B.V
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR INVESTIGATION; IT RAN > 3000 RUNS WITHOUT PROBLEMS. THE DATACARD WAS NOT RETURNED, SO FURTHER INVESTIGATION INTO THE ROOT CAUSE IS NOT POSSIBLE. A NEW UNIT WAS PROVIDED TO THE CUSTOMER WHICH IS RUNNING WITHOUT PROBLEMS ON THE ORIGINAL RAIL.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED TO THE MANUFACTURER AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE UNIT PASSED THROUGH THE FIRST END STOP, THE CHAIR TILTED, AND THEN THE UNIT STOPPED. THE USER FELL FROM THE CHAIR BUT WAS UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588237 HANDICARE FREECURVE PCD HANDICARE STAIRLIFTS B.V FREECURVE

    Patients

    Seq Age Sex Outcome Treatment
    1