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

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

Patient Problems Laceration(s) (1946); Injury (2348); Deformity/ Disfigurement (2360)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

The root cause of the injury was due to the employee not following proper lockout tag out protocol as outlined in the company's internal procedures.Before placing his hand back inside the unit it should have been powered down.The employee was trained on (b)(6) 2018 and his training records showed that he passed the assessment and fully understood the company's protocol.The employee was in a rush that day because he started his day behind schedule and was trying to makeup time to get to his next job.He believed he could quickly remove the screw within the carriage and failed to power down the unit.The employee will receive refresher training on the company's internal lockout tag out procedure.Lockout tag out training will become mandatory reoccurring training for all field technicians every three years.

Event Description

On (b)(6) 2019, an employee was servicing an acorn 130 lift at the home of a customer.The lift was displaying an f1 code (relay fault) and it was determined the pcb needed to be replacement.Unit was powered down and the pcb was removed and replaced.After replacing the pcb, the unit was powered up and tested.While driving the lift up the employee heard a noise due to a screw falling out of the pcb.The screw fell between the chassis and the bottom roller.The employee removed the bottom safety cover, without powering the unit down, reached inside with his left hand to grab the screw.As he was reaching inside simultaneously, his left elbow was on the stairlift remote that he had left on the staircase.The employee did not hear the audible warning that the remote had engaged the chair and the unit moved pinching his finger between the motor gear and the racking on the stairlift rail.This caused a gash in the top of his finger that injured both sides and required stitches on the pad side and the removal of his fingernail.

• Brand Name: 130 ACORN T700 RH
• Type of Device: POWER 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: 9559475
• MDR Text Key: 174859778
• Report Number: 3003124453-2020-00002
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/07/2020

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: 12/09/2019
• Initial Date FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• Is the Device Single Use?: Yes
• 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: 26 YR