MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 130 ACORN T700 LH; POWER STAIRWAY CHAIR LIFT

Device Problems Electrical /Electronic Property Problem (1198); Installation-Related Problem (2965); Power Problem (3010); Intermittent Loss of Power (4016)

Patient Problems Bone Fracture(s) (1870); Damage to Ligament(s) (1952); Multiple Fractures (4519)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

The stairlift was installed on (b)(6) 2020.The user first contacted acorn with a c7 code on 11/6/2020.Acorn was able to fix the issue over the phone.Acorn was contacted four days later (11/10/2020) and an e7 code was reported.A site visit was booked for (b)(6) 2020 to inspect the stairlift; however, the customer canceled that appointment.The customer called acorn on 1/21/2021 to report the stairlift was inoperable but did not mention the user's fell in (b)(6).Acorn inspected the stairlift on 1/22/2021; there was not mention of the (b)(6) 2020 fall during the visit.Acorn became aware of the (b)(6) 2021 incident on (b)(6) 2021 when the user called to report the stairlift was not working.The repeat power issues were caused by the installer did not securing the main power lead and the extension lead.The two wires would become dislodged causing intermittent power to the batteries.

Event Description

The user contacted acorn stairlifts, inc.(acorn) on 2/1/2021 and reported she fell on (b)(6) 2020.The user stated the stairlift was not working at the time of the incident.The user was coming downstairs from her office, the stairlift is installed at her bakery, when she lost her balance and fell down the stairs breaking five ribs.

Event Description

The user called acorn stairlifts, inc.(acorn) on (b)(6) 2021 because her stairlift was stopping.While troubleshooting with a customer support agent the stairlift displayed an e7 code (low battery).The customer support agent asked the user if she heard the stairlift beeping since her last service visit in february.The user replied that it beeps all the time even on the charger.The customer support agent informed the user that the beeping is a signal that the stairlift is not charging.The user was told that the service visit would be set up.The service visit was scheduled for 3/23/2021 due to staffing limitations.On (b)(6) 2021, the user called acorn and stated her stairlift was not working and she had to walk the stairs.While walking the steps she fell and hurt her foot.At the time of the 3/22/2021 phone call the user had not seen a medical professional but stated she would go to the er if the swelling did not go down.Acorn conducted an investigation visit on 3/23/2021.During the visit, the user confirmed that she had to walk the stairs because the stairlift was not operational.She has seen the doctor and her foot was in a boot.

Manufacturer Narrative

There are two factors to the user's stairlift not working.1) the stairlift had a low battery (e7 code) and would only travel down, the customer support agent failed to troubleshoot the stairlift correctly over the phone on (b)(6) 2021.When the user informed the customer support agent that the stairlift had an e7 code she should have been instructed to park the stairlift on the bottom charge point and leave the carriage there until a c6 code (battery full).2) the user drives the carriage back upstairs after riding to the bottom.She mentioned on 3/16/2021 and 3/23/2021 that she was informed at installation the main charge point is at the top, because of this she used her remote to move the stairlift to the top charge point after riding the carriage to the bottom.The stairlift was inspected in 3/23/2021 and all components, including the charge stations, were tested.The only component not working to specification was the remote used to drive the carriage back to the top charge point.Although, the stairlift was installed on (b)(6) 2020 the remote batteries were low and needed to be replaced.The low remote batteries most likely caused the carriage to stop short of the top charge point because the signal was intermittent.If the carriage was not on the charge point, the batteries were not able to charge (leading to the e7 code).The user believed that the carriage was making it to the top charge point, even though the carriage was beeping.On (b)(6) 2021, she mentioned hearing the stairlift beeping all the time even if the carriage was on the charge point.The beeping is a signal that the carriage is not receiving a charge; however, the user had previous charging issues that started shortly after her stairlift was installed.Her previous issues were because the charge stations were not receiving power to charge the batteries and the carriage would beep on the charge stations.Acorn is not able to determine why the remote batteries depleted within five months of use.Acorn will contact the user to ensure she knows that she can park the carriage on both the lower and upper charge point.Acorn will also ensure the user knows how to park the carriage on the charge points properly.Acorn reconfigured the user's rail so she no longer has a hinge rail.This should eliminate the need for her to use the remotes to park the stairlift.

• Brand Name: 130 ACORN T700 LH
• Type of Device: POWER STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• MDR Report Key: 11401655
• MDR Text Key: 234460381
• Report Number: 3003124453-2021-00007
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 113