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

Model Number ACORN 120 LH

Device Problem Installation-Related Problem (2965)

Patient Problem Swelling (2091)

Event Date 01/03/2013

Event Type  malfunction  

Event Description

Client was bringing user down on the lift from mid to lower level.At lower level the lift leaned to the downside causing the user to bump his head on the window sill.

Manufacturer Narrative

Second hand lift was installed by a local construction company not an authorized dealer.Seat post bolts had not been properly torqued to installation specs causing the seat to tilt.

• 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: 4317141
• MDR Text Key: 16188158
• Report Number: 3003124453-2014-00013
• 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: Inspection
• Type of Report: Initial
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACORN 120 LH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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): Other