MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R870

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

It was reported that the user rocks violently in the chair.It is possible that the chair is not appropriate for this user.The product manual warns that "a qualified professional must assess the appropriateness and safety of all equipment for each user".The reporter declined to give any information on the user's age and weight.

Event Description

It was reported that the release head on the gas spring that controls the tilt of the chair broke, allowing the chair seat to tip back.

• Brand Name: RIFTON ACTIVITY CHAIR
• Type of Device: ACTIVITY CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 2255 platte clove rd.; elka park NY 12427
• Manufacturer (Section G): RIFTON EQUIPMENT; 2255 platte clove rd.; elka park NY 12427
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 9981122
• MDR Text Key: 193091006
• Report Number: 1319558-2020-00006
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R870
• Device Catalogue Number: R870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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