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

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

Patient Problem Brain Injury (2219)

Event Date 06/05/2021

Event Type  Injury  

Manufacturer Narrative

Acorn is not able to determine how the user fell out of the stairlift.The stairlift was inspected and tested on 7/8/2021; there was no device malfunction detected.The user should have been able to successfully ride the stairlift without issue on (b)(6) 2021 (the date of the incident).The user and her sister were interviewed by acorn.The sister, who reported the incident, did not see what happen but did find the user on the floor at the bottom of the steps with the carriage three steps up from the charge point.The user was not able to recall any of the events surrounding the incident.The user did state she does not wear the seat.If the seatbelt was used the incident could have been prevented because the seatbelt is designed to keep user in the chair.On 7/8/2021, acorn re-demonstrated how to use the stairlift to both the user and her sister.

Event Description

On (b)(6) 2021, the user's sister contacted acorn stairlifts, inc.(acorn) for service on the stairlift.She mentioned that her sister was riding upstairs and fell off the stairlift three steps up from the bottom charge point.The user was taken to the hospital and spent four days in the intensive care unit (icu) to treat a brain bleed.

• Brand Name: 180 T565 RH
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFT, 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: 12256172
• MDR Text Key: 264515296
• Report Number: 3003124453-2021-00018
• 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: Inspection
• Type of Report: Initial
• Report Date: 07/30/2021

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: 07/02/2021
• Initial Date FDA Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Weight: 95