MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT SENSOR, LARGE

Model Number	FSESL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned for product evaluation and has not arrived.Once it has arrived and the product evaluation findings are available, the findings will be submitted in a supplemental submission.The device history record review has been completed and all manufacturing inspections passed with no non conformances.The other foresight sensor used with this patient will be reported under a separate mdr submission.
Event or Problem Description
It was reported that there was a failure with a foresight sensor, large, during patient use.The user states there were low readings.The value received was less than 40 bilat, without any clinical correlation.There were no error messages.When the sensor was exchanged for a different sensor, there were normal levels obtained, at 70 bilat.The sensor placement was forehead left and right side.Patient skin was prepped with alcohol prior to placement.There was no inappropriate patient treatment administered.The patient demographics were requested but not provided.There was no patient harm.There were two foresight large sensors used with this patient.The other sensor will be reported under a separate mdr submission.
Additional Manufacturer Narrative
The device was returned for evaluation and a product evaluation was completed.The sensor monitored the sto2 readings on a known good working hemosphere unit successfully without any error messages noted.An inspection of the device identified no visible damage.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if any procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.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.Correction was made to investigation codes in h6, type of investigation and investigation findings and investigation conclusions.

• Brand Name: FORESIGHT SENSOR, LARGE
• Common Device Name: FORESIGHT SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn richards ; one edwards way; irvine, CA 92614
• MDR Report Key: 18522502
• Report Number: 2015691-2024-00439
• Device Sequence Number: 3665981
• Product Code: MUD
• UDI-Device Identifier: 00690103208146
• UDI-Public: (01)00690103208146(17)250425(11)230425(10)43202318
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2025
• Device Model Number: FSESL
• Device Lot Number: 43202318
• 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: 01/01/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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