MAUDE Adverse Event Report: ACORN STAIRLIFTS INC ACORN 120; STAIRWAY CHAIRLIFT

Model Number ACORN 120 RH

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Client was demonstrating his new lift for his nephew when the seat assembly tilted downwards.The seat bolt appeared to be missing.The nephew was able to catch the user to avert a fall.No injuries reported.

Manufacturer Narrative

Installation problem with installer not attaching a seat bolt to the stairlift at time of installation.Customer reported immediately and acorn stairlifts attended and removed the effected unit and replaced with new.Installer retrained on making sure all items on installation checklist are complete.

• Brand Name: ACORN 120
• Type of Device: STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS INC; orlando FL
• Manufacturer Contact: tracy bero ; 7335 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 4602996
• MDR Text Key: 5627603
• Report Number: 3003124453-2015-00011
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACORN 120 RH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 68