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

Device Problem Installation-Related Problem (2965)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/18/2019

Event Type  Injury  

Manufacturer Narrative

Direct cause is stairlift programming was not to proper operating specification for the vertical bends (slightly too fast), causing pressure on the anti-tilt (rail follower) assembly.This pressure caused gouging along the rail and over time caused irregular wear and damage to the anti-tilt/rail follower itself.The damage to the anti-tilt/rail follower along with the gouging in the rail led to the level bogie binding in place on the rail and stopping the stairlift on (b)(6) 2019 while the customer was riding the stairlift upstairs.The root cause of the lift being programmed too fast could not be determined at this time, as evidence shows that the programming issue could have happened as far back as (b)(6) 2017 and four technicians have programmed the lift since that time.

Event Description

On sunday (b)(6) 2019 in the evening approximately 11:30pm the customer was using the lift to go upstairs.After making the turn the stairlift stopped and she had to get out.She was able to dismount and with the help of her husband she walked up the remaining three steps.About 15 min later the customer decided to walk downstairs.She fell from the top step to the landing.She then tried getting up and her husband came to assist her to make her way down the stairs.She fell again down the remaining steps.At this point she did not seek medical attention but mention her ankle was sore.On the return service visit (b)(6) 2019 the technician noting the customer was not at home and asked her whereabouts.The customer's husband stated she went to the doctor and found out that she had a broken ankle.She was in rehab healing.

• Brand Name: GENERIC 180 T565 LH US
• Type of Device: POWER 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: shawn herbst ; 7001 lake ellenor drive; orlando, FL 32809 ; 8885650410
• MDR Report Key: 9084953
• MDR Text Key: 163220287
• Report Number: 3003124453-2019-00008
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• 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: 74 YR
• Patient Weight: 68