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	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.No product was returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.
Event or Problem Description
As reported, during this target market release (tmr), with a patient in bypass (non-pulsatile mode), of this alta monitor, the foresight cable connected to the left foresight sensor placed on the brain provided higher values than the right-side sensor.The foresight cable was changed and the issue was solved.No error messages were displayed.There was no allegation of patient injury.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section d9, h6 (investigation findings) and h6 (investigations conclusions).Finally the device was received for evaluation.The report could not be confirmed.From visual inspection no defects were identified on this fore-sight module.The foresight module (fsm) was plugged into a known good unit (kgu) tom connected to a kgu hem1 monitor.Tissue oximetry saturation (sto2) simulators were connected and sto2 values were measured during 24 hours.The obtained values remained steady at 65% +-5 and no error messages were displayed.The device was tested according to internal procedures and it passed the test.The source of failure could not be determined as no defect was found during device evaluation.Also, based on the available information there is no evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.

• 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
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20607840
• Report Number: 2015691-2024-08326
• Device Sequence Number: 12596853
• Product Code: DQK
• UDI-Device Identifier: 00690103208573
• UDI-Public: (01)00690103208573(11)230912
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown