MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES FORE-SIGHT ELITE MONITOR; OXIMETER, TISSUE SATURATION

Model Number	01-06-3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/05/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.A device history record review was performed, and no related non-conformances were found.No escalation is required.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Event or Problem Description
During use of a foresight elite monitor, a 15-year-old male patient was declared brain dead following an open-heart surgery for replacement of pulmonary valve replacement and pfo closure.Per the logs, the foresight elite monitor displayed significant drops in tissue oxygen saturation.It is suspected that that the alarm volume was set to whisper during the case.The facility stated that the surgeon was unaware of the low tissue oxygen saturation (sto2) values during the case.The facility does not suspect a product malfunction.
Additional Manufacturer Narrative
A product evaluation was performed at the customer site to assess the functionality and integrity of the foresight elite monitor and pre-amp cables.In addition, the analysis also included a review of the monitor's case data log for the reported event.The product investigation and the case data log analysis concluded that the monitor and the two pre-amp cables used in the complaint case functioned as intended.The monitor passed all testing including an alarm volume test.The alarm volume test was performed measuring the alarm audio volume three times for all alarm levels using a calibrated sound level meter.Monitor case data log analysis: system triggered low and high sto2 alarms according to the user settings.It was confirmed that values were displayed for up to four channels every two seconds.Four body locations were monitored: left and right cerebral, left and right flank muscles.As defined in the user manual, multiple informational alarms, and medium and low priority alarms occurred.The sto2 alarm limits (%) were set by the user.It was concluded that there was no product nonconformance.The device alarmed as intended.

• Brand Name: FORE-SIGHT ELITE MONITOR
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFE SCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618
• MDR Report Key: 22366674
• Report Number: 2015691-2025-05308
• Device Sequence Number: 9582757
• Product Code: MUD
• UDI-Device Identifier: 10609538630009
• UDI-Public: (01)10609538630009(11)190627
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01-06-3000
• Device Catalogue Number: 01-06-3000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Death
• Patient Age: 15 YR
• Patient Sex: Male