MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT OXIMETER CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMFSM10
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	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include: dqe.Catheter, oximeter, fiber-optic.Qaq.Adjunctive predictive cardiovascular indicator.Mud.Oximeter, tissue saturation.Dxn.System, measurement, blood-pressure, non-invasive.Dsb.Plethysmograph, impedance.Qms.Adjunctive open loop fluid therapy recommender.Fll.Thermometer, electronic, clinical.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review was completed and no related non-conformances were found.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
As reported during use in a patient this foresight elite tissue oximeter module indicated an elevation in sto2 values.The expected values were around 70%, but the displayed values exceeded 90%.No treatment was administered to the patient based on the inaccurate values.When this foresight elite tissue oximeter module was replaced, the issue was resolved.There was no allegation of patient injury.The device will be available for evaluation.
Additional Manufacturer Narrative
One foresight elite tissue oximeter module was returned for evaluation.The device evaluation could not confirm reported customer complaint of an indication in elevation in sto2 values.There was a spring clip missing.No error messages or physical damage was observed.The device passed all functional testing.There was no defect found.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore a root cause could not be established.

• Brand Name: FORESIGHT OXIMETER CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23535242
• Report Number: 2015691-2025-09215
• Device Sequence Number: 21374197
• Product Code: DQK
• UDI-Device Identifier: 00690103210927
• UDI-Public: (01)00690103210927(11)231128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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: HEMFSM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown