BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACORN STAIRLIFT 130

    MDR report key: 15224523 · Received August 15, 2022

    Report

    Report Number
    3003124453-2022-00010
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 1, 2022
    Report Date
    August 12, 2022
    Manufacturer
    ACORN STAIRLIFTS, INC.
    Product Code
    PCD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT, WORK COMPLETION REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER CONTACTED ACORN STAIRLIFTS, INC. (ACORN) FOR SERVICE TO THE STAIRLIFT. HE REPORTED THAT THE STOPPED MID TRAVEL, THE TOGGLES INOPERATIVE. ACORN'S REPRESENTATIVE ASKED THE CUSTOMER IF HE WAS ABLE TO DO SOME TROUBLESHOOTING AND HE RESPONDED, YES. HE WAS INSTRUCTED BY ACORN TO MOVE THE STAIRLIFT TO THE TOP OF THE STAIRS WITH THE REMOTE. THE CUSTOMER ASKED HIS WIFE TO GET THE REMOTE AND TAKE THE STAIRLIFT UP INSTEAD SHE DROVE IT DOWN TO THE BOTTOM. THE CUSTOMER DISEMBARKED AT THE BOTTOM OF THE STAIRS AND INSPECTED THE STAIRLIFT AS REQUESTED BY ACORN'S AGENT. HE THEN GOT BACK ON THE STAIRLIFT AND ACORN'S AGENT INFORMED HIM THAT THE STAIRLIFT NEEDED TO BE TAKEN BACK TO THE TOP. ACORN'S AGENT STATED" I WANT YOU TO USE THE REMOTE CONTROL, DO YOU HAVE ONE AVAILABLE TO YOU DOWN THERE?". THE CUSTOMER DID NOT ANSWER THE QUESTION. HE YELLED UP THE STAIRS TO HIS WIFE "(B)(6), BRING ME UP WITH THE REMOTE CONTROL". THE CUSTOMER'S WIFE THEN USED THE REMOTE TO MOVE THE CHAIR, WITHIN A FEW SECONDS THE CUSTOMER'S LEFT ARM MADE CONTACT WITH THE HAND RAIL. HIS WIFE CONTINUED TO OPERATE THE STAIRLIFT PINNING HIS ARM BETWEEN THE SEAT AND THE HANDRAIL. HE WENT TO THE EMERGENCY ROOM WHERE THEY GAVE HIM A TETANUS SHOT AND PUT HIS ARM IN SLING. HIS ARM IS SWOLLEN FROM THE ELBOW TO HIS HAND. HE WAS GIVEN MORPHINE AND AN ANTI-INFLAMMATORY DRUG. AT THIS TIME, THE INJURED PARTY REQUIRES A FOLLOW UP VISIT WITH A BONE SPECIALIST. ISSUE WAS THAT THE CUSTOMER WAS NOT PROPERLY SEATED IN THE STAIRLIFT AS INSTRUCTED BY ACORN; HE WAS LEANED OVER THE ARM OF THE STAIRLIFT, LEANING OVER WHICH IS WHAT CAUSED HIS ARM TO BE PINNED BETWEEN THE HANDRAIL AND THE STAIRLIFT WHEN HIS WIFE OPERATED THE STAIRLIFT VIA REMOTE. ACORN ALSO INSTRUCTED HIM TO USE THE REMOTE AT THE BOTTOM TO TAKE HIMSELF UP. THOSE INSTRUCTION WERE NOT FOLLOWED BY THE CUSTOMER. (B)(6) 2022 INJURY UPDATE: ACORN CONTACTED THE CUSTOMER ON (B)(6) 2022 TO FOLLOW UP ON HIS INJURY. HE SAW THE BONE SPECIALIST ON (B)(6) 2022. HIS ARM WAS STILL TOO SWOLLEN FOR THE DR. TO PROPERLY ASSESS THE EXTENT OF THE INJURY. THE DR. PRESCRIBED AN MRI AND COMMUNICATED THAT THE CUSTOMER NEEDS TO REVISIT IN A MONTH. THE EXTENT OF THE INJURY IS STILL UNKNOWN. THE INVESTIGATION RESULTS FOUND THAT THERE WAS NO MALFUNCTION OF THE STAIRLIFT. THE INCIDENT WAS CREATED BY THE INSTRUCTIONS GIVEN BY THE ACORN REPRESENTATIVE NOT BEING FOLLOWED DURING THE TROUBLESHOOTING SESSION OF THE STAIRLIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264361 ACORN STAIRLIFT 130 POWERED STAIRWAY CHAIRLIFT PCD ACORN STAIRLIFTS, INC. 130 LH US

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Other