MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CCOMBO V; CATHETER

Catalog Number 777HF8

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Anesthesia cnra reported to materials management and safety that the edwards life science swan-ganz combo v was inserted into the patient without any issues, but monitor would not read cardiac output from the inserted catheter.Possibly a broken thermistor may have caused this issue.Device was not provided to safety, only packaging.

• Brand Name: CCOMBO V
• Type of Device: CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 4637652
• MDR Text Key: 15314194
• Report Number: 4637652
• Device Sequence Number: 1
• Product Code: DQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 03/20/2015

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: Nurse
• Device Catalogue Number: 777HF8
• Device Lot Number: 5988101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONNECTED TO THE THERMODILUTION CATHETER AND; FOUND NO ISSUES WITH THIS MONITOR.; NO, BIO-MEDICAL CHECKED CARDIAC MONITOR THAT WAS