BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACORN 180 T565

    MDR report key: 15860844 · Received November 24, 2022

    Report

    Report Number
    3003124453-2022-00018
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    September 27, 2022
    Report Date
    November 24, 2022
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    PMA / PMN Number
    N/A#S-P#N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS INCIDENT WAS THE USER NOT SITTING BACK IN THE PROPER RIDING POSITION, CAUSING EXTRA STRESS TO BE PUT ON THE TOP ROLLERS AND OSG OVER TIME WHICH CAUSED IRREGULAR/EXCESSIVE PREMATURE WEAR TO THE TOP ROLLERS AND OSG. THIS CAUSED THE OSG TO ENGAGE. THE USER ALSO CONTRIBUTED TO THE INCIDENT BY USING THE STAIRLIFT OUT OF SPECIFICATION WHEN USING IT WITHOUT WEARING THE SEATBELT. AT THE TIME OF INSTALLATION A USER MANUAL INDICATING THE SEAT BELT MUST BE WORN TO OPERATE THE STAIRLIFT WAS LEFT WITH THE CUSTOMER. HAD THE USER BEEN RIDING IN THE PROPER RIDING POSITION AND THE SEAT BELT BEEN WORN, WHEN THE OSG ENGAGED AND THE STAIRLIFT STOPPED THE USER WOULD HAVE REMAINED ON THE SEAT.

    Description of Event or Problem · 0

    ON (B)(4) 2022, THE CLIENT CONTACTED ACORN STAIRLIFTS, INC. (ACORN) FOR SERVICE ON THE STAIRLIFT. HIS ACCOUNT OF THE INCIDENT WAS: ON (B)(6) 2022, HIS WIFE FELL FROM THE STAIRLIFT AFTER IT STOPPED UNEXPECTEDLY. SHE FELL OFF THE STAIRLFIT AND DOWN THE REMAINING STEPS. SHE REQUIRED SURGERY THAT INCLUDED SCREWS TO HER RIGHT SIDE THIGH AND HIP. AFTER THE SURGERY, SHE WAS SENT TO REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731979 ACORN 180 T565 POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC. 180 T565 LH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other| H