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
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 provided stable values.There was no allegation of patient injury.The device was available for evaluation.
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.
Additional Manufacturer Narrative
Updated section b5: no error message was displayed.The patient was not treated according to drifting values.Added information to section d9, h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Patient demographics unable to be obtained.The device was received for evaluation.The report of drifting values could not be confirmed.An additional issue of the spring clip missing was noted and it was attached.No physical damaged was observed.The device passed all functional tests.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.Based on the available information and, since the report could not confirmed during the product evaluation, there is not enough evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.
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 provided stable values.No error message was displayed.The patient was not treated according to drifting values.There was no allegation of patient injury.

• 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: 22991033
• Report Number: 2015691-2025-07339
• Device Sequence Number: 8868755
• 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): 12/01/2025

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
• 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: 11/24/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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