MAUDE Adverse Event Report: OPSENS INC. OPTOMONITOR 3; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number F2310

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Patient underwent cardiac catheterization on (b)(6) 2024, during procedure the box that shows percentages of estimated heart block stopped communicating.Delayed case for approximately 10 minutes while troubleshooting.'' ref-f2330, (b)(6)".

• Brand Name: OPTOMONITOR 3
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): OPSENS INC.
• MDR Report Key: 19153460
• MDR Text Key: 340859868
• Report Number: MW5154051
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F2310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Patient Sequence Number: 1