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

Model Number ACORN 120 RH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Paralysis (1997)

Event Date 08/15/2013

Event Type  Injury  

Manufacturer Narrative

Most likely underlying cause was user losing his balance when stepping down between upper and lower mid landing.During settlement negotiations, wife admitted that user had a stroke unrelated to use of the stairlift.Both lifts returned to manufacturer for inspection and found to be operating to specifications.

Event Description

Client's wife called in on (b)(6) 2013 to complain that the stairlift had broken down 3 days after install on (b)(6) 2013 (was able to troubleshoot over the phone and lift worked as intended).She requested removal and a refund then said her husband had fallen on (b)(6)2013 and was now in the hospital paralyzed on the right side.There were no witnesses to the fall but she thinks he may have fallen from the stairlift.

• 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 32809-0000 ; 4076500216
• MDR Report Key: 4331756
• MDR Text Key: 22225355
• Report Number: 3003124453-2014-00010
• 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: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/28/2014

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: ACORN 120 RH
• Device Catalogue Number: 110102457607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2013
• Initial Date FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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