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

Device Problem Installation-Related Problem (2965)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

The stairlift stopped on the user because as the carriage traveled on the rail the vibration of the movement caused a h2 code (leveling system over reacting).Field operations management reviewed the pictures taken at installation and noticed that the installer failed to secure the floor mounts of the railing into the floor substrate.Acorn 180 training manual des-6 requires that floor mount screws be secured into countersunk holes, on the support leg, to prevent the rail from vibrating during travel.

Event Description

On (b)(6) 2021 , the user returned a called to acorn stairlifts, inc.(acorn) and reported that she fell dismounting the stairlift.She stated that on (b)(6) 2021 she was traveling upstairs when she remembered that she forgot shoe and need to go back down stairs.While trying to go back down stairs the stairlift stopped.The user assumed she was close to the floor and stepped out of the stairlift.The user has an eye condition (fuchs' dystrophy) that affects her vision and she could not see the floor and fell into the wall opposite the stairlift.According to the investigation interview on (b)(6) 2021 , the user broke her left hand and three ribs on her left side.

• Brand Name: 180 T565 LH
• Type of Device: POWERED STAIRWAY CHAIRLIFT
• 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: 11828663
• MDR Text Key: 252689878
• Report Number: 3003124453-2021-00013
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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: 76 YR
• Patient Weight: 48