BEUDAMED
    FDA Adverse Event Injury Summary report: N

    180 T565 RH

    MDR report key: 12256172 · Received July 30, 2021

    Report

    Report Number
    3003124453-2021-00018
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    June 5, 2021
    Report Date
    July 30, 2021
    Manufacturer
    ACORN STAIRLIFT, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACORN IS NOT ABLE TO DETERMINE HOW THE USER FELL OUT OF THE STAIRLIFT. THE STAIRLIFT WAS INSPECTED AND TESTED ON 7/8/2021; THERE WAS NO DEVICE MALFUNCTION DETECTED. THE USER SHOULD HAVE BEEN ABLE TO SUCCESSFULLY RIDE THE STAIRLIFT WITHOUT ISSUE ON (B)(6) 2021 (THE DATE OF THE INCIDENT). THE USER AND HER SISTER WERE INTERVIEWED BY ACORN. THE SISTER, WHO REPORTED THE INCIDENT, DID NOT SEE WHAT HAPPEN BUT DID FIND THE USER ON THE FLOOR AT THE BOTTOM OF THE STEPS WITH THE CARRIAGE THREE STEPS UP FROM THE CHARGE POINT. THE USER WAS NOT ABLE TO RECALL ANY OF THE EVENTS SURROUNDING THE INCIDENT. THE USER DID STATE SHE DOES NOT WEAR THE SEAT. IF THE SEATBELT WAS USED THE INCIDENT COULD HAVE BEEN PREVENTED BECAUSE THE SEATBELT IS DESIGNED TO KEEP USER IN THE CHAIR. ON 7/8/2021, ACORN RE-DEMONSTRATED HOW TO USE THE STAIRLIFT TO BOTH THE USER AND HER SISTER.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE USER'S SISTER CONTACTED ACORN STAIRLIFTS, INC. (ACORN) FOR SERVICE ON THE STAIRLIFT. SHE MENTIONED THAT HER SISTER WAS RIDING UPSTAIRS AND FELL OFF THE STAIRLIFT THREE STEPS UP FROM THE BOTTOM CHARGE POINT. THE USER WAS TAKEN TO THE HOSPITAL AND SPENT FOUR DAYS IN THE INTENSIVE CARE UNIT (ICU) TO TREAT A BRAIN BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148734 180 T565 RH POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization