MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 130 ACORN RH; POWER STAIRWAY CHAIR LIFT

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Ems called acorn starilifts, inc.Customer support on 12/5/2019 and asked us how to hand wind the stairlift to the top of the rail so the stairlift would clear egress to transport the user down the stairs.The stairlift was installed on 4/19/2011.The stairlift has had an annual service inspection once a year since 2016 on the following dates 6/6/2016, 5/19/2017, 6/12/2018, and 8/23/2019.On (b)(6) 2019 the client reported the stairlift running slow and the batteries were replaced.Until (b)(6) 2019, the stairlift has been working with no incidents reported continuously since (b)(6) 2011.At this time root cause can't be determined as it is not currently possible to reconstruct what caused the user's knees to make contact with the wall.He is currently in rehab and unable to be measured and/or demonstrate what kept him from clearing the handrail.There were no reported ride quality or clearance issues prior to the incident on (b)(6) 2019.Only the staircase measurements are on file, the user's measurements are not documented and will have to be obtained on-site when the user has returned from rehab in late january/early february.

Event Description

On (b)(6) 2019, the user's son called in to schedule service for his father (the user).The stairlift had stopped working during use.He stated that his father had used the stairlift to go upstairs and his knees were dragging against the wall; his left knee became trapped where the handrail attaches to the handrail bracket (3rd bracket from the bottom).The user continued to drive the stairlift up as his left foot pressed into the footrest causing an injury to his left ankle.It was at this point the stairlift quit working and the user was stuck with his left leg pinned between the footrest and the handrail.Ems was called to assist and remove the user from the stairlift.Ems took the handrail down to free the user's leg and transported him to get medical attention.

Event Description

On (b)(6) 2019, the user's son called in to schedule service for his father (the user).The stairlift had stopped working during use.He stated that his father had used the stairlift to go upstairs and his knees were dragging against the wall; his left knee became trapped where the handrail attaches to the handrail bracket (3rd bracket from the bottom).The user continued to drive the stairlift up as his left foot pressed into the footrest causing an injury to his left ankle.It was at this point the stairlift quit working and the user was stuck with his left leg pinned between the footrest and the handrail.Ems was called to assist and remove the user from the stairlift.Ems took the handrail down to free the user's leg and transported him to get medical attention.On (b)(6) 2020, acorn stairlifts, inc.(acorn) interviewed the customer.The customer was coming up stairs "sidesaddle" when his left knee wedged under the wrought iron handrail.The customer confirmed the information his son provided on (b)(6) 2019.

Manufacturer Narrative

Ems called acorn customer support on (b)(6) 2019 and asked how to hand wind the stairlift to the top of the rail so the stairlift would clear egress to transport the user down the stairs.The stairlift was installed on (b)(6) 2011.The stairlift has had an annual service inspection once a year since 2016 on the following dates (b)(6) 2016, (b)(6) 2017, (b)(6) 2018, and (b)(6) 2019.On (b)(6) 2019 the client reported the stairlift running slow and the batteries were replaced.Until (b)(6) 2019, the stairlift has been working with no incidents reported continuously since (b)(6) 2011.On (b)(6) 2020, acorn inspected the stairlift for proper operation.The seat to handrail measurement is approximately 23", and the customer's back to knee measured approximately 23".It is not possible for the customer to use the stairlift without sitting sideways.The customer has to position their knees in the direction they are traveling to utilize the stairlift and demount the chair at the top or bottom.The stairlift was installed before acorn established quality processes that would prevented out of specification installation.In 2015, acorn instituted qa procedures for pre-installation checks as well as escalation procedures for any stairlifts in the field not installed to specification.Acorn sent the customer an out of specification letter informing them of proper riding position and that staircase modifications are necessary to bring the stairlift into specification.

• Brand Name: 130 ACORN RH
• Type of Device: POWER STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando, fl FL 32809
• MDR Report Key: 9549482
• MDR Text Key: 178532495
• Report Number: 3003124453-2020-00001
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRACE; WALKER; WALKER; WHEELCHAIR
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 79