MAUDE Adverse Event Report: ACORN STAIRLIFTS INC ACORN 180; STAIRWAY CHAIRLIFT

Model Number ACORN 180 RH

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Device Handling Problem (3265)

Patient Problems Bone Fracture(s) (1870); Fracture, Arm (2351)

Event Date 12/14/2014

Event Type  Injury  

Event Description

Client was riding the stairlift in the downward direction and the lower safety edge of the footrest engaged on the last step before the bottom causing the lift to stop.Client did not realize she was not at the bottom, stepped off the lift and fell breaking an arm and a leg.

Manufacturer Narrative

Inspection revealed that lift was installed to specifications.Technician could not replicate the issue in the normal riding position.Was only able to engage the lower safety edge of the footrest by standing erect on the footrest thereby placing more pressure on it.Patient's weight at survey was documented at (b)(6) which is within the safe weight specifications for the lift.During inspection, a family member revealed that the user's weight exceeds the weight limit that the lift is designed to carry.Most likely underlying cause of the safety edge engaging is excess wight.Discussed proper lift specifications for riding with user and family.Reviewed weight restriction.User understands that lift is to be used only within weight specifications.

• Brand Name: ACORN 180
• 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: 4584898
• MDR Text Key: 5337396
• Report Number: 3003124453-2015-00009
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Patient Monitoring
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ACORN 180 RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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
• Patient Age: 71 YR
• Patient Weight: 136