MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R860

Device Problems Break (1069); Material Fragmentation (1261); Unintended Movement (3026)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

We are still waiting for additional information about the user and the incident.

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.

Manufacturer Narrative

The distributor was not able to provide information on how the chair was used.

• Brand Name: RIFTON ACTIVITY CHAIR
• Type of Device: ACTIVITY CHAIR
• Manufacturer (Section D): RIFTON EQUIPMENT; 2255 platte clove rd.; elka park NY 12427
• MDR Report Key: 10694514
• MDR Text Key: 219197900
• Report Number: 1319558-2020-00011
• 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: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 10/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: R860
• Device Catalogue Number: R860
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 46