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

Model Number ACORN 120 RH

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

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

Event Date 01/02/2013

Event Type  malfunction  

Event Description

Client's wife started to ascend the steps using the stairlift without fastening the seatbelt.She heard a grinding sound and fell from the lift.No injuries.

Manufacturer Narrative

Lift was surveyed for use by husband but wife is using too.User's wife not wearing seatbelt per mfrs instructions.Grinding noise attributed to a motor failure possibly due to exceeding weigh limit specifications since the inline fuse has blown which suggests over-amping.Both users were re-educated on using the lift per mfrs specifications.

• 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: 4602998
• MDR Text Key: 18933174
• Report Number: 3003124453-2015-00007
• 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: Repair
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2013
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2012
• 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