MAUDE Adverse Event Report: THE FURNISS CORPORATION LTD DC2480 KNEE CPM; EXERCISER, POWERED

Model Number DC2480

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

Cpm (continuous passive motion) machine can turn on, but you cannot control the rom (range of motion), flexion and extension numbers.

• Brand Name: DC2480 KNEE CPM
• Type of Device: EXERCISER, POWERED
• Manufacturer (Section D): THE FURNISS CORPORATION LTD; 15812 state route 56 w; mount sterling OH 43143
• MDR Report Key: 17622967
• MDR Text Key: 321958852
• Report Number: 17622967
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DC2480
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2023
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1