BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREECURVE

    MDR report key: 8030467 · Received November 1, 2018

    Report

    Report Number
    3007802293-2018-00042
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    June 5, 2018
    Report Date
    November 1, 2018
    Manufacturer
    HANDICARE STAIRLIFTS B.V
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETROSPECTIVE MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    WHEN TAP TO FLOOR WAS USED BY THE CUSTOMER ON THE FREECURVE IN COMBINATION WITH A HINGE RAIL, IT OCCURRED THAT THE FREECURVE UNIT DID NOT STOP AT THE HINGE RAIL. THE CUSTOMER WAS MOST LIKELY NOT WEARING A SEAT BELT, CUSTOMER SAID SHE FELL FORWARD A BIT, MORE OF A JERK AND BRUISED HER ARM. POLICY WOULD BE THAT TAP TO FLOOR OPTION IS "MANUALLY" SWITCHED OFF IN THE SOFTWARE OF THE POWERPACK CONFIGURATOR IF A HINGE RAIL CONFIGURATION IS USED: HOWEVER, IT APPEARS THAT THIS WAS NOT ALWAYS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868946 FREECURVE STAIRLIFTS PCD HANDICARE STAIRLIFTS B.V

    Patients

    Seq Age Sex Outcome Treatment
    1