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

Model Number ACORN 120 LH

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Inadequate User Interface (2958)

Patient Problem Contusion (1787)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

While attempting to swivel chair at top of stairway to get off starilift user put hand onto arm of stairlift and the stairlift moved slightly resulting in a fall down stairway.

Manufacturer Narrative

Interaction between customer and product while getting off stairlift resulted in movement.Toggle was accidentally engaged.On investigation spring on activation switch was missing, unable to identify if this moved during the interaction and no longer could be found on site.Spring replaced.

• 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: 4602999
• MDR Text Key: 17998079
• Report Number: 3003124453-2015-00003
• 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: 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 LH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2014
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 100