MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 782F75M

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  Injury  

Event Description

Svo2 device connector broke off of swan.Wires exposed were covered with "gauze" and taped.

• Brand Name: SWAN CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 18826359
• MDR Text Key: 336943571
• Report Number: MW5152262
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 782F75M
• Device Lot Number: 65261812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Female