MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE FORESIGHT MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMFSM10
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda product codes: 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 has not been completed.The device history record was reviewed; no related non-conformances were found.No escalation is required at this time.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
It was reported that during use, the hemosphere foresight elite monitor displayed low sto2 readings.The cable was replaced with a new one, which resolved the issue.It has been confirmed that no patient injury or harm occurred in connection with this event.The affected cable is expected to be returned for evaluation.
Additional Manufacturer Narrative
The foresight module was returned for evaluation.The reported issue of inaccurate readings could not be confirmed.No readings were displayed while module was connected to a known working hemosphere monitor.A "fault: sto2 a1 - faulty sensor" message was displayed after the hemfsm10 initialized without the sensor simulator being connected.While connected to known working sensors, no errors occurred.Both sensors were recognized and channel 1 and 2 displayed 65% sto2 (+/- 5%) with simulators connected.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As no defect was found, a product non-conformance or device failure could not be confirmed and no root cause could be determined.In addition, a device history record review was completed and the product passed without nonconformances.

• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 23659261
• Report Number: 2015691-2025-09605
• Device Sequence Number: 21339021
• Product Code: DQK
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(17)271004(11)221005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2026

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
• Operator of Device: Health Professional
• Device Model Number: HEMFSM10
• Device Catalogue Number: HEMFSM10
• Device Lot Number: 21120910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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
• Patient Sex: Unknown