MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FORESIGHT; OXIMETER, TISSUE SATURATION

Model Number	FSESL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of foresight sensor, in an open heart surgery, the number was greater than 90 however when changed out the new sensor monitored the patient in the 70s.A new sensor was applied by the physician which worked as expected.There was no patient injury nor was any treatment administered based on inaccurate values.
Additional Manufacturer Narrative
The device will not be returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.The lot number was not provided thus a device history record was not reviewed.No corrective actions will be taken at this time.The ifu contains the following warnings and precautions: avoid positioning the sensor over hair, air sinus, hematomas, or broken skin.Avoid attaching the sensor to sites with excess adipose, ascites, or edema.The materials used in the manufacture of the sensor were not designed for reuse.Reuse can cause the sensor not to perform as intended.

• Brand Name: FORESIGHT
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22771689
• Report Number: 2015691-2025-06517
• Device Sequence Number: 9760288
• Product Code: MUD
• UDI-Device Identifier: 00690103208146
• UDI-Public: 00690103208146
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: Health Professional
• Device Model Number: FSESL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown