MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 834F75

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Did not transduce pressure lines.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 16844325
• MDR Text Key: 314370177
• Report Number: MW5117153
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2023

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 Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 834F75
• Device Catalogue Number: 834F75
• Device Lot Number: 64305110
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2023
• Patient Sequence Number: 1