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

Model Number	HEMFSM10
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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 part of this monthly review.
Event or Problem Description
As reported, during a demo use, the sto2 (tissue oxygen saturation) channels of this hemosphere foresight module were exchanged; channel 1 was labelled as 2 and the channel 2 was labeled as 1.Therefore, in the monitor sto2 (a2) values corresponded to the sensor connected in channel 1, and vice versa.There was no patient involved.
Additional Manufacturer Narrative
Added information to section d9 and h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report could be confirmed.Visually, it was detected that, as reported, the sto2 channels labels were exchanged.A pra has been initiated for this issue.Current preliminary cause suggest that the labeling swap issue originated from the manufacturer.The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.

• Brand Name: HEMOSPHERE FORESIGHT OXIMETER CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 24019200
• Report Number: 2015691-2026-10289
• Device Sequence Number: 21075300
• Product Code: DQK
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(17)271024(11)221025
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown