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

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause of hinge strut becoming loose was gasket inside strut losing integrity, releasing pressure.

Event Description

Client was picking up bags off the floor and hinged rail came down and hit her knee.Fractured patella.

• 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: 6283982
• MDR Text Key: 66005927
• Report Number: 3003124453-2017-00003
• 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: company representative
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/27/2017

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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: 81 YR
• Patient Weight: 68