MAUDE Adverse Event Report: TRANSONIC SYSTEMS INC. TRANSONIC; FLOWMETER, BLOOD, CARDIOVASCULAR

Model Number HQN3MB

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Event Description

After the aneurysm was clipped, the surgeon attempted to use the flow probe and it did not work.After extensive troubleshooting with the actual machine, a new flow probe supply was opened and worked within normal limits.

• Brand Name: TRANSONIC
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): TRANSONIC SYSTEMS INC.; 34 dutch mill rd; ithaca NY 14850
• MDR Report Key: 8775540
• MDR Text Key: 150560256
• Report Number: 8775540
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HQN3MB
• 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: 07/01/2019
• Date Report to Manufacturer: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA