MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

Model Number R870

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that the caregiver sustained knee injuries due to transporting the user in the rifton activity chair between classrooms and outdoors.

• 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: 15213908
• MDR Text Key: 297759155
• Report Number: 1319558-2022-00006
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention