MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT LARGE SENSOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FSESL

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

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.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Patient demographics not obtained at this moment.

Event Description

As reported, with this foresight sensor measurement showed 90 on the forehead when the value expected was 70-80.No error message was displayed.It was tried different area of the same patient, and even on different persons.There was no allegation of patient injury.The device was available for evaluation.Patient demographics not obtained.

Manufacturer Narrative

One foresight sensor was received for a full evaluation.The report of measurement issue was not able to be confirmed.No visible damage was observed from the sensor during visual examination.Sensor monitored tissue oxygen saturation (sto2) on hemosphere monitor without any error message.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.No root cause could be identified for the issue since no defect was found during the product evaluation.

• Brand Name: FORESIGHT LARGE SENSOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18912843
• MDR Text Key: 337764970
• Report Number: 2015691-2024-02040
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Model Number: FSESL
• Device Lot Number: 41202248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1