MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R860

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

We have requested, but not yet received, additional information about the user, and how the device is used.

Event Description

Inspection of broken parts returned to the factory showed 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: 10801316
• MDR Text Key: 216938856
• Report Number: 1319558-2020-00013
• 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: user facility
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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