MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CARDIAC OUTPUT BRIDGE; TRANSDUCER, BLOOD-PRESSURE

Catalog Number 041400350A

Device Problem Leak/Splash (1354)

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

Event Date 02/12/2018

Event Type  malfunction  

Event Description

At the beginning of the case a leak in the bridge was noted.The bridge was switched out with another so the case could be finished.

• Brand Name: CARDIAC OUTPUT BRIDGE
• Type of Device: TRANSDUCER, BLOOD-PRESSURE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• MDR Report Key: 7348867
• MDR Text Key: 102769008
• Report Number: 7348867
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018,03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/19/2022
• Device Catalogue Number: 041400350A
• Device Lot Number: 11186049
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR