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

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

The stairlift was fully inspected; no operational or mechanical issue were present to prevent the customer from taking the stairlift to the bottom of the stairs.Acorn stairlifts, inc.(acorn) has documentation that the customer was demonstrated how to use the stairlift at least four times.However, acorn's demonstration protocol and the user manual provided to the customers does not adequately express the importance of mounting and disembarking stairlifts with hinges at the bottom of the rail.The regional manager attempted to demonstrate how to mount and disembark the stairlift at the bottom of the rail during the (b)(6) 2020 visit.The customer declined to participate in the demonstration, because she was too tired from her physical therapy session, instead the regional manager demonstrated mounting and disembarking while the customer watched from another room.The customer stated that she does not wish to get on and off the stairlift at the bottom of the rail because that is not what she has previously done.The customer was informed of proper mounting and disembarking procedures on two other occasions.On 3/4/2020, when the customer called in to report the incident and again on 3/26/2020 when the customer contacted acorn customer service.Acorn will revise all necessary labeling to state that one must mount and disembark hinge stairlifts at the bottom of the rail.

Event Description

The customer climbed the first three stairs to use the stairlift to on (b)(6) 2020.The stairlift was parked on the lower charge station above the hinge.The customer does not always use the hinge to bring the stairlift to the bottom of the rail; instead, she gets on and off the stairlift at the charge station.While trying to get onto the stairlift on (b)(6) 2020, the customer had the armrest down in the riding position and bumped the toggle with her arm.The stairlift moved down the stairs and pushed her over.The customer fell breaking her right ankle, and fracturing her back.

• Brand Name: 130 ACORN LH US
• Type of Device: POWER STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando, fl
• Manufacturer (Section G): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando, fl
• Manufacturer Contact: dorian pearson-shaver ; 7001 lake ellenor drive; orlando, fl ; 6500216169
• MDR Report Key: 9925055
• MDR Text Key: 190965234
• Report Number: 3003124453-2020-00004
• 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: Other
• Type of Report: Initial
• Report Date: 04/03/2020

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: 03/04/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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: 75 YR
• Patient Weight: 70