MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 180 T565 RH; POWERED STAIRWAY CHAIR LIFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Acorn inspected the stairlift on (b)(6) 2021 and was not able to determine what caused the stairlift to stop (in july or recently).The only issues that the field technician found were: dead batteries most likely because of age.Worn osg most likely because of age.Damage seat interlock (left arm toggle) most likely because of misuse.None of the component failures listed would result in the intermittent stopping that the customer reported.Acorn is not able to determine if 'emergency dismount' procedures would have prevented the injury because the exact location of the carriage (at the time of the incident) is not known.'emergency dismount' procedures are only effective if the customer can swivel towards the stairs.Depending on how close to the bottom charge point the customer was in july he might not have been able to swivel the chair towards the stairs.Since acorn cannot determine root cause, no further action will be taken at this time.

Event Description

On (b)(6) 2021, the customer contacted acorn stairlifts, inc.(acorn) to request service for his stairlift.The customer claimed that the stairlift was intermittently stopping.The stairlift stopped mid-rail and would not move in either direction.The customer stated that this issue happened previously in (b)(6) 2021, which resulted in an injury.In july, the customer was riding the stairlift down when the stairlift stopped before the charge point.The customer thought they were close to the ground and exited the stairlift; however, the chair was too far off the ground and the customer hit the back of his right leg on the footrest.His right leg became bruised.After several days, the customer went to urgent care because the bruise was not improving.His leg was examined and in addition to bruising, he damaged blood vessels forming blood clots.The customer was prescribed a blood thinner for six months to dissolve the blood clots that formed due to the injury.

• Brand Name: 180 T565 RH
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• MDR Report Key: 12518815
• MDR Text Key: 273767664
• Report Number: 3003124453-2021-00020
• 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
• Report Date: 09/23/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR
• Patient Weight: 103