MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	782F75M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Calibrating the swan machine in prep for the case in ct kept erroring.Changed out oximetry cable, and rebooted swan machine with no change.Switched out the kit and the error code ended ruling the kit being faulty.

• Brand Name: SWAN-GANZ VIP
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 24480977
• Report Number: 24480977
• Device Sequence Number: 13331389
• Product Code: DQO
• UDI-Device Identifier: 00690103197303
• UDI-Public: (01)00690103197303
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/12/2026
• Report Date (Section F): 02/12/2026

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 Model Number: 782F75M
• Device Catalogue Number: 782F75M
• Device Lot Number: 65457646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/12/2026