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

Model Number 746F8

Device Problem Failure to Calibrate (2440)

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

Event Date 07/01/2018

Event Type  malfunction  

Event Description

Physician could not get the swan-ganz to calibrate.

• Brand Name: SWAN-GANZ CCOMBO
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7676978
• MDR Text Key: 113692941
• Report Number: 7676978
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103002881
• UDI-Public: (01)00690103002881
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2018
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 71