MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CCOMBO V; CATHETER, OXIMETER, FIBEROPTIC

Model Number 777F8

Patient Problem Insufficient Information (4580)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

When prepping room for procedure, prior to patient entry, staff tested swan-ganz due to historical issues.Swan-ganz pressures would not register.Device taken out of service, new device obtained, no further issues.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17669313
• MDR Text Key: 322479087
• Report Number: 17669313
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2023

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 Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64912992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2023
• Date Report to Manufacturer: 09/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA