BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC 180 T565 LH US

    MDR report key: 9662578 · Received February 3, 2020

    Report

    Report Number
    3003124453-2020-00003
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    December 8, 2019
    Report Date
    March 19, 2020
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A REGIONAL MANAGER INSPECTED THE STAIRLIFT ON (B)(6) 2020, ACORN DETERMINED IMPROPER DATUM SET/ PROGRAMMING AND NOT FOLLOWING PROPER SERVICING PROCEDURES WHEN SERVICING THE UNIT CAUSED THE STAIRLIFT TO BECOME INOPERABLE. DURING THE (B)(6) 2020 SITE VISIT THE STAIRLIFT WAS REPROGRAMMED AND REPAIRED BACK TO OPERATING SPECIFICATIONS.

    Description of Event or Problem · 0

    ON THE EVENING OF (B)(6) 2019, THE CUSTOMER CALLED INTO ACORN STAIRLIFTS, INC. (ACORN) BECAUSE HER LIFT WAS INOPERABLE. THE CUSTOMER HAD CALLED IN EARLIER THAT DAY REQUESTING SERVICE BECAUSE THE STAIRLIFT WAS RUNNING SLOWER THAN NORMAL. A SERVICE VISIT WAS BOOK FOR THE FOLLOWING MONDAY (B)(6) 2019. SOMETIME BETWEEN WHEN THE CUSTOMER CALLED ACORN ON (B)(6) 2019 AND WHEN ACORN ARRIVED AT THE CUSTOMER'S HOME ON (B)(6) 2019 THE CUSTOMER FELL TRYING TO USE THE STAIRS AND WAS TAKEN TO THE HOSPITAL. ACORN WAS NOT AWARE OF THE INCIDENT UNTIL (B)(6) 2020 WHEN THE CUSTOMER'S FRIEND CONTACTED ACORN TO SCHEDULE A SERVICE APPOINTMENT TO GET THE STAIRLIFT OPERATIONAL AGAIN IN ANTICIPATION OF THE CUSTOMER'S RETURN HOME. ON (B)(6) 2020 AN ACORN SERVICE TECH WAS IN THE CUSTOMER'S HOME AND RECEIVED CONFIRMATION FROM THE CUSTOMER'S FRIEND THAT THE CUSTOMER DID FALL DOWN THE STAIRS AND FRACTURE HER NECK AND SEVERAL RIBS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, ACORN IS UNABLE TO DETERMINE THE ROOT CAUSE BECAUSE THERE IS INSUFFICIENT INFORMATION REGARDING THE CUSTOMER INCIDENT. THE CUSTOMER IS STILL IN REHABILITATION. ACORN HAS ATTEMPTED TO CONTACT THE CUSTOMER FOR AN INTERVIEW AND TO PERFORM ANOTHER SITE VISIT BUT HAS BEEN UNSUCCESSFUL TO DATE. ON (B)(6) 2020 THE CUSTOMER'S FRIEND WAS CONTACTED AND INFORMED ACORN THE CUSTOMER WOULD BE HOME ON (B)(6) 2020 AT THE EARLIEST. UPON COMPLETION OF A FULL INVESTIGATION, ACORN WILL SEND A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON THE EVENING OF (B)(6) 2019, THE CUSTOMER CALLED INTO ACORN STAIRLIFTS, INC. (ACORN) BECAUSE HER LIFT WAS INOPERABLE. THE CUSTOMER HAD CALLED IN EARLIER THAT DAY REQUESTING SERVICE BECAUSE THE STAIRLIFT WAS RUNNING SLOWER THAN NORMAL. A SERVICE VISIT WAS BOOK FOR THE FOLLOWING MONDAY (B)(6) 2019. SOMETIME BETWEEN WHEN THE CUSTOMER CALLED ACORN ON (B)(6) 2019 AND WHEN ACORN ARRIVED AT THE CUSTOMER'S HOME ON (B)(6) 2019 THE CUSTOMER FELL TRYING TO USE THE STAIRS AND WAS TAKEN TO THE HOSPITAL. ACORN WAS NOT AWARE OF THE INCIDENT UNTIL (B)(6) 2020 WHEN THE CUSTOMER'S FRIEND CONTACTED ACORN TO SCHEDULE A SERVICE APPOINTMENT TO GET THE STAIRLIFT OPERATIONAL AGAIN IN ANTICIPATION OF THE CUSTOMER'S RETURN HOME. ON (B)(6) 2020 AN ACORN SERVICE TECH WAS IN THE CUSTOMER'S HOME AND RECEIVED CONFIRMATION FROM THE CUSTOMER'S FRIEND THAT THE CUSTOMER DID FALL DOWN THE STAIRS AND FRACTURE HER NECK AND SEVERAL RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123647 GENERIC 180 T565 LH US POWER STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization WALKER| WALKER