MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CCOMBO; CATHETER, FLOW DIRECTED

Model Number	746F8
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician could not get the swan-ganz to calibrate.

• Brand Name: SWAN-GANZ CCOMBO
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7676978
• Report Number: 7676978
• Device Sequence Number: 1384404
• Product Code: DYG
• UDI-Device Identifier: 00690103002881
• UDI-Public: (01)00690103002881
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/02/2018
• Report Date (Section F): 07/02/2018

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
• Operator of Device: No Information
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 61286376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 71
• Date Report Sent to FDA: 07/02/2018