MAUDE Adverse Event Report: EDWARDS LIFESCIENCE IRVINE FORE-SIGHT ELITE; OXIMETER, TISSUE SATURATION

Model Number	01-06-3000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Stroke/CVA (1770)
Type of Reportable Event	Serious Injury
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 investigation is completed.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 a part of the monthly review.
Event or Problem Description
It was reported that the customer has been having some issues with foresight.The customer stated that they have been having issues with the sensor staying on the patient, several times they have not been able to get readings on patients and they have also said that they have had issues with numbers that do not match the patients condition.The customer mentioned an instance of a patient a few months ago that was showing normal numbers on the foresight but had a stroke.It is unknown if the stroke occurred in the or or the icu after surgery.
Additional Manufacturer Narrative
Multiple attempts were made for additional information and to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

• Brand Name: FORE-SIGHT ELITE
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20510744
• Report Number: 2015691-2024-08013
• Device Sequence Number: 15584640
• Product Code: MUD
• UDI-Device Identifier: 10609538630009
• UDI-Public: 10609538630009
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01-06-3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown