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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not been received yet.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, this hemosphere foresight cable provided sto2 (tissue oximetry saturation) drifting values on one side of patient.The values drifted between 60 and 90 in one minute.The other side provide stable values.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
Updated: b5 (description of event), d9 (device availability), g6 (type of report), h3 (device evaluated by the manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions).Added: h2 (type of follow-up).The device of this complaint was received by our technical service center for a full examination.The reported issue was unable to be confirmed.However, another issue was found: the spring clip was missing.No additional physical damage was observed on the returned device.Additionally, the device passed all functional tests according to internal procedures.Based on further engineering investigation, a definite root cause was unable to be established.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.No further action 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 part of this monthly review.
Event or Problem Description
As reported, this hemosphere foresight cable provided sto2 (tissue oximetry saturation) drifting values on one side of patient.The values drifted between 60 and 90 in one minute.The other side provide stable values.No error message was displayed.The patient was not treated according to drifting values.There was no allegation of patient injury.Patient demographics were unable to be provided.

• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22990955
• Report Number: 2015691-2025-07338
• Device Sequence Number: 9413195
• Product Code: DQK
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(11)230331
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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?: Yes
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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