BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 ACORN RH

    MDR report key: 11483433 · Received March 15, 2021

    Report

    Report Number
    3003124453-2021-00008
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    April 13, 2020
    Report Date
    March 15, 2021
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S HUSBAND THINKS HIS WIFE LEANED TOO HARD ON THE ARMREST CAUSING IT TO BREAK. THE CUSTOMER NOT WEARING THEIR SEAT BELT CONTRIBUTED TO THEM FALLING OUT OF THE SEAT. UNDER CONTROLLED LAB CONDITIONS, THE SUPPLIER WAS UNABLE TO REPLICATE THIS FAILURE MODE WITH NO ROOT CAUSE BEING ESTABLISHED. UNDER THE CIRCUMSTANCES OF THE FAILURE MODE, IT HAS ALSO BEEN CONCLUDED THAT THE DAMAGE RECORDED CAN ONLY HAVE BEEN INTRODUCED BY CUSTOMER MISUSE OR INAPPROPRIATE HANDLING DURING FITMENT AND REMOVAL OF THE SEAT ASSEMBLY. BASED OFF THE SUPPLIERS' INSPECTION AND HUSBAND'S STATEMENT THE MOST LIKELY UNDERLYING CAUSE IS THE CUSTOMER MISUSING THE ARMREST.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND CALLED ACORN STAIRLIFTS, INC. (ACORN) ON (B)(6) 2020 REQUESTING REPAIRS TO THE ARMRESTS OF THE SEAT. HE STATED A FEW DAYS PRIOR HIS WIFE WAS RIDING THE STAIRLIFT UPSTAIRS, WITHOUT A SEAT BELT, WHEN HALF WAY UP SHE CALLED TO HER HUSBAND SAYING SHE WAS FALLING. HE CAME TO THE TOP OF THE STAIRS TO SEE SHE ALREADY FELL AND WAS GOING DOWN THE STEPS. HE SAID THE CHAIR CONTINUED MOVING UP STAIRS AFTER HIS WIFE FELL. THE CUSTOMER WAS TREATED FOR A BUMP ON THE HEAD AND A FRACTURE TO HER RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380368 130 ACORN RH POWERED STAIRWAY CHAIR LIFT PCD ACORN STAIRLIFTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization SCOOTER| WHEELCHAIR