MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORE-SIGHT ELITE; TISSUE OXIMETER PREAMP

Model Number	01-06-3100
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	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts were made to secure return of the device; however, the device was not sent back for evaluation.Without the return of the device, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.The device history record review was not completed as the serial number was not provided.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.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 during use the foresight cable had inaccurate parameters on the left channel.No additional information was available.There is no patient injury.The device is not available for evaluation.

• Brand Name: FORE-SIGHT ELITE
• Common Device Name: TISSUE OXIMETER PREAMP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22074942
• Report Number: 2015691-2025-04069
• Device Sequence Number: 12937270
• Product Code: MUD
• UDI-Device Identifier: 10609538631006
• UDI-Public: 10609538631006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 01-06-3100
• Was Device Available for Evaluation?: No
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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