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

Lot Number 63187217

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2020

Event Type  malfunction  

Event Description

Unable to obtain blood temperature for thermodilution cardiac output on swan ganz catheter.Cardiac output cable changed.Ge maclab rebooted.Problem did not resolve.New swan ganz inserted and problem resolved.Fda safety report id# (b)(4).

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC.; irvine CA 92614
• MDR Report Key: 10800868
• MDR Text Key: 215489740
• Report Number: MW5097685
• Device Sequence Number: 1
• Product Code: DQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2020

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: 06/03/2022
• Device Lot Number: 63187217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 77