BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREECURVE

    MDR report key: 10843045 · Received November 16, 2020

    Report

    Report Number
    3013423626-2020-00023
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 16, 2020
    Manufacturer
    HANDICARE STAIRLIFTS B.V
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    HANDICARE, THE IMPORTER, NOTIFIED THE MANUFACTURER, HANDICARE STAIRLIFTS BV, OF THE INCIDENT ON (B)(6) 2020. THIS UNIT HAS NOT YET BEEN RETURNED. WHEN RECEIVED, IT WILL BE SENT TO HANDICARE STAIRLIFTS BV FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE FINDINGS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE INITIAL TEST RIDE BY THE DEALER PRIOR TO SIGNING OFF THE LIFT TO THE CUSTOMER, THE CHAIR TILTED MORE THAN 90 DEGREES. THE DEALER WAS RIDING IN THE UP DIRECTION AT THE TIME, AND WAS ABLE TO CATCH HIMSELF TO PREVENT A FALL. THE DEALER REPLACED THE POWERPACK WITH A NEW UNIT WHICH SUCCESSFULLY PASSED ALL TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311558 FREECURVE CHAIR LIFT PCD HANDICARE STAIRLIFTS B.V C0020091

    Patients

    Seq Age Sex Outcome Treatment
    1