MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. ACORN 180 T565; POWERED STAIRWAY CHAIR LIFT

Model Number T565

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problem Vertebral Fracture (4520)

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Attachment #1: work completion report.Completed documents are attached with submission.The investigation is ongoing therefore signed off investigation doucmentation will be submitted within the next 7 business days.

Event Description

On 9/16/2022, the customer contacted acorn stairlifts, inc.And reported that the stairlift was stopping intermittently while in use.During this call, he also requested his annual service.An annual service package was not purchased previous to the call for service.No return call was made to the client.On 9/21/2022, the client returned a call to schedule his annual service.In this call, he made acorn aware that he had fallen on the stairs.He was not able to use the stairlift because it was malfunctioning so he climbed the stairs on his hands and knees.When he attempted to stand, he lost his balance, fell backwards down the stairs resulting in a back injury.Medical attention was required and it was determined that he had cracked a vertebrae.

• Brand Name: ACORN 180 T565
• Type of Device: POWERED 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: melissa field ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 15656490
• MDR Text Key: 302249988
• Report Number: 3003124453-2022-00017
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/23/2022

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: Lay User/Patient
• Device Model Number: T565
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 109 KG