MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE FORESIGHT; OXIMETER, TISSUE SATURATION

Model Number	FSESL
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the obviously high reading of above 90 was displayed soon after applying a set of foresight sensors on the patient's head.The sensors were replaced, and the measurement was stable at around 65.There was no patient complications reported.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Additional Manufacturer Narrative
One foresight sensor size large without attached liner was returned for evaluation.There was no visible damage observed from the sensor.There was no visible damage or contamination noticed from the connector area.The reported issue of high values was not able to be confirmed.The sensor monitored sto2 on a hemosphere monitor without any error messages.Both the sto2 and signal quality index (sqi) values were stable.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.A device history record review was unable to be completed as the lot number is unknown.The lot number for this device was not provided and is unknown, therefore, the full udi number is not available.The primary device identifier (di) number was provided with report id: (b)(4).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.

• Brand Name: FORESIGHT
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 20784008
• Report Number: 2015691-2024-08949
• Device Sequence Number: 8942847
• Product Code: MUD
• UDI-Device Identifier: 00690103208146
• UDI-Public: (01)00690103208146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143675
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: FSESL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown