MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R780

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

The rifton activity chair may not be appropriate for this user.The product manual warns that "a qualified professional must assess the appropriateness and safety of all equipment for each user", and "this product is intended for use by clients of unreliable judgment.Adult supervision is required at all times".

Event Description

It was reported that the user was sitting in the chair when the mother left the room momentarily.When the mother returned, she reportedly found that the user had unbuckled the seatbelt and slid down, catching her neck on the butterfly harness.The user was not injured.

• Brand Name: RIFTON ACTIVITY CHAIR
• Type of Device: ACTIVITY CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 2255 platte clove road; elka park NY 12427
• Manufacturer (Section G): RIFTON EQUIPMENT; 2255 platte clove road; elka park NY 12427
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 6841668
• MDR Text Key: 85145842
• Report Number: 1319558-2017-00002
• Device Sequence Number: 1
• Product Code: INN
• 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
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: R780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1