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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Head Injury (1879); Localized Skin Lesion (4542)

Event Type  Injury  

Manufacturer Narrative

The customer failed to use the stairlift as intended.The stairlift is intended to take users the length of the stairs without interruption.When the customer decided to dismount mid travel, she stopped using the stairlift for its intended use.The customer's stairlift was installed on (b)(6) 2009, prior to acorn developing 'emergency dismount' procedures and the revision of the user manual to include the 'important safety notes' pages.On (b)(6) acorn provided the customer a full demonstration (which included emergency dismount procedures).On (b)(6) corn sent the customer current user manual and a quick user guide.

Event Description

The customer contacted acorn stairlifts, inc.On 8/21/2021 to request service for her stairlift.During the 8/21/2021 phone call, the customer reported two years ago she fell out of the stairlift.Around (b)(6) 2019, the customer was riding the stairlift upstairs to use the bathroom when she could not wait any longer.The customer stopped the stairlift before reaching the top; however, she does not remember anything about the fall.The customer woke up at the bottom of the stairs with her leg in pain.The customer called 911 and was taken to the hospital.The customer received seven stitches in her head and had a bump in her leg.

• Brand Name: 130 ACORN RH
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• MDR Report Key: 12507846
• MDR Text Key: 272521700
• Report Number: 3003124453-2021-00019
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/21/2021

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?: No
• Initial Date Manufacturer Received: 08/21/2021
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2009
• 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
• Treatment: CANE
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 77