BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREECURVE

    MDR report key: 8030721 · Received November 1, 2018

    Report

    Report Number
    3007802293-2018-00044
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    November 9, 2017
    Report Date
    November 1, 2018
    Manufacturer
    HANDICARE STAIRLIFTS B.V
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETROSPECTIVE MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    LIFT TILTED SIDEWAYS. OUTGOING SHAFT COULD SLIP IN THE LAST GEAR IN THE GEARBOX. INVESTIGATION SHOWED THAT WHERE NORMALLY THE PINION IS PUSHED ON THE SHAFT, CREATING DENTS AND A FORM FIT, THIS WAS NOT THE CASE IN THIS GEARBOX. MOST PROBABLY; THEREFORE, THE TOLERANCES OF THE INNER HOLE IN THE LAST GEAR WERE OUT OF SPECIFICATION. DRAWINGS ARE OWNED BY (B)(4); SUPPLIER OF THE PARTICULAR FAULTY GEARBOX. WE REQUESTED FEEDBACK FROM (B)(4) MULTIPLE TIMES REGARDING ROOT CAUSE ANALYSIS BUT SO FAR HANDICARE HAS RECEIVED NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869990 FREECURVE STAIRLIFTS PCD HANDICARE STAIRLIFTS B.V

    Patients

    Seq Age Sex Outcome Treatment
    1