MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R870

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

The client was reportedly left unsupervised for 20 minutes.The product manual for all rifton products clearly states that adult supervision is required at all times.In addition, the product manual and product labeling remind caregivers to check for proper fit of all straps and harnesses after each adjustment to ensure that the client is secure and properly supported.

Event Description

It was reported that the client was sitting in the rifton activity chair and was left alone and unsupervised for 20 minutes.According to the reporter, during this time the client slid down in the chair, became caught on the chest harness, and was found to be choking.The client was not hurt.

• 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 ; 2032 rt 213; rifton, NY 12471 ; 8456587722
• MDR Report Key: 5875364
• MDR Text Key: 52719454
• Report Number: 1319558-2016-00001
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: R870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 YR