MAUDE Adverse Event Report: ACORN MOBILITY SERVICES LTD ACORN STAIRLIFTS; STAIRWAY CHAIRLIFT

Model Number 180

Device Problems Break (1069); Fracture (1260); Defective Component (2292)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/08/2015

Event Type  Injury  

Event Description

User was travelling on stairlift in down direction from top floor when seat pad base became detached from hinges of seat resulting in seat pad base and user falling.

• Brand Name: ACORN STAIRLIFTS
• Type of Device: STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN MOBILITY SERVICES LTD; station road; millennium business park, station road; steeton, west yorkshire BD20 6RB; UK BD20 6RB
• Manufacturer Contact: william waddell ; station road; millennium business park, station road; steeton, west yorkshire BD20 -6RB ; UK BD20 6RB ; 35291000
• MDR Report Key: 5382778
• MDR Text Key: 36587022
• Report Number: 3006310491-2016-00001
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• 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: 79 YR