MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC ACORN 130 RH; POWERED STAIRWAY CHAIRLIFT

Device Problems Crack (1135); Material Distortion (2977)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause could not be determined since client's legal representative refused to allow an investigation.Physical evidence review from photos suggests most likely underlying cause to be an impact to the seat with considerable force, not normal use within specification.Investigation will be conducted once legal representative releases the seat to acorn.

Event Description

Grandson of user called to report that seat had snapped and user had fallen.

• Brand Name: ACORN 130 RH
• Type of Device: POWERED STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer Contact: tracy bero ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 6244093
• MDR Text Key: 64557426
• Report Number: 3003124453-2017-00001
• 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: Patient Family Member or Friend
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2016
• 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: 86 YR