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

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

Patient Problem Laceration(s) (1946)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

The customer's jacket was pulled into the drive motors, which caused a voltage surge cutting power to the stairlift.The customer used the stairlift out of specification.Page five of the user manual tells customers to secure lose articles of clothing before operating the stairlift.Acorn provided the customer a copy of the acorn 180 curved stairlift user manual on 6/27/2019.Moreover, the customer failed to follow the emergency dismount procedures listed in page 19 of the user manual.If the seat was swiveled and the customer exited the stairlift on the bottom step; the chance of her falling would have been reduced.Acorn will send the customer an out of specification letter reminding them to always secure lose articles and to swivel the chair in the up direction when exiting the stairlift (even in the case of an emergency).Acorn will also send the customer a quick user guide since one was not provided at the time of installation.

Event Description

On (b)(6) 2021 , the customer contacted acorn stairlifts, inc.(acorn) to report an accident involving her stairlift.The day before ((b)(6) 2021 ) she was using the stairlift to go upstairs, the jacket she was wearing got caught in the carriage just as the stairlift made the first turn at the bottom of the stairs.The customer was unable to restart the stairlift and had to dismount.She slid off the chair but could not touch the floor and fell forward hitting her head on the light switch on the opposing wall.The impact with the switch gave her two lacerations.The customer went to the hospital for treatment but turned down stiches requesting steri-strips instead.

• Brand Name: 180 T565 LH
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer (Section G): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer Contact: dorian pearson-shaver ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 11711097
• MDR Text Key: 252689380
• Report Number: 3003124453-2021-00012
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/22/2021

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?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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: 81 YR
• Patient Weight: 77