BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDICARE STAIRLIFTS 2000

    MDR report key: 8292779 · Received January 31, 2019

    Report

    Report Number
    3011268530-2019-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    November 29, 2017
    Report Date
    January 20, 2020
    Manufacturer
    HANDICARE ACCESSIBILITY UK LTD
    Product Code
    PCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    38,793 END STOPS SUPPLIED FROM OCT 16 - JAN 19 AND 3 REPORTED FAILURES FROM OCT 16 - JAN 19 AT THE COMPONENT FAILURE RATE OF : 0.008% IT IS SUSPECTED THAT THE TRUNNION HAS REPETITIVELY KNOCKED AGAINST THE END STOP WHICH OVER TIME HAS WEAKENED THE WELD AND THE WELD EVENTUALLY FAILED. CORRECTION: JULY 2018 A NEW UNIVERSAL END STOP WAS LAUNCHED. FURTHER IMPROVEMENTS ARE BEING MADE UNDER THE SAME ECN TO IMPROVE FITNESS. 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

    ON 29/11/2017, THE USER CALLED TO AND INFORMED THAT THE LIFT CAME OFF THE TRACK. IT LOOKS AS THOUGH THE END STOPS AND FINAL STOP FAILED. WHEN THE LIFT WAS REMOVED FROM THE TRACK THE FINAL LIMIT SWITCH IN THE TRUNNION FAILED, SWITCH ASSY AND BARS ARE BENT NOW BUT THAT WAS BECAUSE OF IMPACT DAMAGE. ON 16/07/2018 THE MECHANICAL END STOP OF THE RAIL HAS COME OFF. THE STAIRLIFT WAS NOT IN USE WHILE THE INCIDENT OCCURED AND NO INJURIES REPORTED ON BOTH INCIDENTS.

    Additional Manufacturer Narrative · 1

    FILING RETROSPECTIVE MEDICAL DEVICE REPORTS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE USER CALLED TO AND INFORMED THAT THE LIFT CAME OFF THE TRACK. IT LOOKS AS THOUGH THE END STOPS AND FINAL STOP FAILED. WHEN THE LIFT WAS REMOVED FROM THE TRACK THE FINAL LIMIT SWITCH IN THE TRUNNION FAILED, SWITCH ASSY AND BARS ARE BENT NOW BUT THAT WAS BECAUSE OF IMPACT DAMAGE ON (B)(6) 2018 THE MECHANICAL END STOP OF THE RAIL HAS COME OFF. THE STAIRLIFT WAS NOT IN USE WHILE THE INCIDENT OCCURED AND NO INJURIES REPORTED ON BOTH INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87157 HANDICARE STAIRLIFTS 2000 STAIRLIFT PCD HANDICARE ACCESSIBILITY UK LTD

    Patients

    Seq Age Sex Outcome Treatment
    1