MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R850

Device Problems Break (1069); Collapse (1099)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

We are waiting the return of the chair to complete the investigation.

Event Description

It was reported that the client was in the activity chair when "the chair collapsed", and the client fell to the floor.

Manufacturer Narrative

Inspection of the returned item and information provided by the equipment dealer showed that the user may have exceeded the item's maximum user weight limit, and was a very active individual.The customer had made a modification to the item to accommodate a larger user, and the item showed wear consistent with a large and active user aggressively rocking both side to side as well as front to back.It is likely that this unusual rocking motion, combined with the apparent size and weight of the user, caused the bolts to fatigue, and then fail.Inspection of the returned item and information provided by the equipment dealer suggest that this chair may not have been appropriate for this user.In the product manual we state the following: "a qualified professional must assess the appropriateness and safety of all equipment for each user." "do not use this product for clients outside the height and weight limits specified in this manual.".

• Brand Name: RIFTON ACTIVITY CHAIR
• Type of Device: ACTIVITY CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 2255 platte clove road; rifton 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: 6499560
• MDR Text Key: 73234813
• Report Number: 1319558-2017-00001
• 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,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: R850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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