MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP; CATHETER, FLOW DIRECTED

Model Number 831F75

Patient Problem Insufficient Information (4580)

Event Date 08/26/2023

Event Type  malfunction  

Event Description

Swan failure.Unable to obtain hemodynamic numbers.Monitor, lines, cables, cable boxes checked by >2 staff members.Core temp not detected by monitor.Last set of hemodynamics done at approximately 0400.Inotropes weaned, unable to obtain f/u ci/co.

• Brand Name: SWAN-GANZ VIP
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 18011543
• MDR Text Key: 326617449
• Report Number: 18011543
• Device Sequence Number: 1
• Product Code: DYG
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male