BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDICARE STAIRLIFTS 2000

    MDR report key: 8304644 · Received February 5, 2019

    Report

    Report Number
    3011268530-2019-00005
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    July 1, 2018
    Report Date
    January 20, 2020
    Manufacturer
    HANDICARE ACCESSIBILITY UK LTD
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTION: JULY 2018, A NEW UNIVERSAL END STOP WAS LAUNCHED. FURTHER IMPROVEMENTS ARE BEING MADE UNDER THE SAME ECN TO IMPROVE FITABILITY. ALL RECORDED FAILURES OF THE END STOPS ARE WITH THE OLD DESIGNS MADE PRIOR TO JULY 2018. 25 PRODUCTION SAMPLES OF THE UNIVERSAL END STOP WERE TESTED AND THEY SUCCESSFULLY STOPPED THE POWER PACK LOADED WITH 342.5KG WITH ALL ELECTRICAL SAFETIES REMOVED. THE WELDING WAS INSPECTED BY R&D AND QUALITY. FURTHER TESTING WAS PERFORMED ON THE UNIVERSAL END STOP OVER 66,530 CYCLES AND PASSED WITH NO REPORTED ISSUES. ALL REPORTED FAILURES HAVE OCCURED WITH AN OLDER DESIGN. MANUFACTURER INTRODUCED THE UNIVERSAL END STO IN JULY 2018 AND FAILURES ARE REPORTED.

    Description of Event or Problem · 0

    MECHANICAL END STOP WELD BROKE OF THE RAIL AND THE PACK CAME OFF THE RAIL. NO INJURIES REPORTED.

    Additional Manufacturer Narrative · 1

    RETROSPECTIVE MDR REPORTING.

    Description of Event or Problem · 1

    MECHANICAL END STOP WELD BROKE OF THE RAIL AND THE PACK CAME OFF THE RAIL. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100456 HANDICARE STAIRLIFTS 2000 STAIRLIFTS PCD HANDICARE ACCESSIBILITY UK LTD INTERNAL CURVE

    Patients

    Seq Age Sex Outcome Treatment
    1