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

Catalog Number 7466HF8

Device Problem Failure to Calibrate (2440)

Patient Problem No Information (3190)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

The device failed to calibrate.

• Brand Name: SWAN-GANZ
• Type of Device: SWAN GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC.; one edwards way; irvine CA 92614
• MDR Report Key: 5100055
• MDR Text Key: 26650415
• Report Number: 5100055
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/04/2016
• Device Catalogue Number: 7466HF8
• Device Lot Number: 59967285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 87