MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TECHNOLOGY SARL SWAN GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 831HF75

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

The swan ganz from edwards lifesciences were tested prior to being used on a patient.The balloons would not deflate on multiple occasions in the time period of (b)(6) 2015 through (b)(6) 2015.

• Brand Name: SWAN GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES TECHNOLOGY SARL; one edwards way; irvine CA 92614
• MDR Report Key: 4861853
• MDR Text Key: 20751075
• Report Number: 4861853
• Device Sequence Number: 0
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/08/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 831HF75
• Device Lot Number: 59938035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2015
• Patient Sequence Number: 1