BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACORN 180

    MDR report key: 15128642 · Received July 29, 2022

    Report

    Report Number
    3003124453-2022-00003
    Event Type
    Injury
    Date Received
    July 29, 2022
    Date of Event
    September 4, 2021
    Report Date
    July 11, 2022
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION REPORT, ASSOCIATED WORK ORDER REPORTS, M5 DIAGNOSTIC INSPECTION REPORT, APPLICABLE PHOTO EVIDENCE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE CUSTOMER'S DAUGHTER CONTACTED ACORN STAIRLIFTS, INC. TO REPORT THAT THE STAIRLIFT WAS INOPERABLE, DISPLAYING AN F6 CODE, (MEANING: LIFT HAS OVER TRAVELLED IT'S PARKING POSITION OR THE SWITCH HAS BEEN ACTIVATED ACCIDENTLY, ACORN 180 TRAINING MANUAL, FEB, 2018). ON (B)(6) 2021, SERVICE WAS CONDUCTED AND THE FINAL LIMIT SWITCH WAS FOUND OUT OF POSITION. THE FIELD TECHNICIAN READJUSTED THE FINAL LIMIT SWITCH AND INSPECTED THE STAIRLIFT PER F509.0.3; THE STAIRLIFT PASSED ALL INSPECTION CRITERIA. ACORN WAS CONTACTED AGAIN ON (B)(6) 2021, THE CUSTOMER STATED THAT THE F6 CODE DISPLAYED AGAIN. ACORN CONTACTED THE CUSTOMER ON (B)(6) 2021 TO CONFIRM A SERVICE APPOINTMENT FOR (B)(6) 2021, AT THIS TIME THE CUSTOMER'S DAUGHTER INFORMED ACORN THAT ON (B)(6) 2021 AT 2AM, HER MOTHER HAD ATTEMPTED TO CLIMB THE STAIRS AND FELL, RESULTING IN A BROKEN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500270 ACORN 180 180 T565 LH USA PCD ACORN STAIRLIFTS, INC. 180 T565 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other