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

Device Problem Installation-Related Problem (2965)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

On 9/23/2016 the lift was installed by the tech to manufacturer's specifications.The customer called in on (b)(6) 2016 requesting rail alterations.The customer support agent who handled the (b)(6) 2016 call informed the customer the lift was installed to specifications; however, on 10/13/2016 a service call was scheduled.During the 10/24/2016 service visit the field technician stated, "customer is an engineer and wanted it done his way." the tech moved the upper rail closer to the hand rail and reconfigured the bottom rail so the chair was farther away from the door, per the customer's request.The reconfiguration resulted in the bottom rail being 27 inches off the ground.The height of the bottom 180 wrap caused the pcb to lose it's spot on the rail.There was a breakdown scheduled on (b)(6) 2017 because the chair was out of level, the customer's son-in-law called the day of the appointment to cancel the visit.On (b)(6) 2017 the customer was using the lift going downstairs when the lift tilted and stopped.Since the rail was too high off the ground the customer and her husband had difficulty getting her off the seat, resulting in them falling backwards and hitting the coffee table, fracturing her rib.

Event Description

The lift was traveling towards the bottom, there was a program shift causing an interruption in travel and the level safety to engage.Customer was 27 inches off the ground.Her husband attempted to help her off.She slid off the seat and they both fell against the coffee table, resulting in a hairline rib fracture.

• Brand Name: ACORN 180 LH
• Type of Device: POWER STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809 5792
• Manufacturer Contact: tracy bero ; 7001 lake ellenor drive; orlando, FL 32809-5792 ; 4076500216
• MDR Report Key: 7073142
• MDR Text Key: 93416757
• Report Number: 3003124453-2017-00009
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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: 85 YR
• Patient Weight: 45