MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE SENSOR, LARGE; FORESIGHT SENSOR

Model Number FSESL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

The foresight sensor was discarded and not available for return and evaluation.Therefore, the device history service review cannot be completed and the udi number cannot be provided.There were two foresight sensors placed on the patient.A supplemental report will be submitted when the other sensor mdr submission number is available.H3 other text: discarded at facility.

Event Description

It was reported that during patient use with a foresight sensor, large, that a pressure injury developed, hapi.While in the icu, the foresight tissue oximetry system was in place monitoring the patient.The patient was also wearing a headband for continuous temperature monitoring.There were two foresight sensors placed on the patient's forehead.The patient's skin was prepped with alcohol prior to placement.The sensors were placed under the headband for several days, it is unknown exactly how long, several days is an estimate from the clinician.When the foresight sensors were removed, there was a breakdown of the skin due to the pressure of the oximetry headband.There was no report of inappropriate patient treatment.Patient demographics were not provided.The edwards representative discussed with the facility that it is not recommended that the foresight sensors be placed under the headband.

Manufacturer Narrative

The device was discarded at the facility and will not be returned for evaluation.This submission is to send the mdr report id number for the other foresight sensor involved in this event, 2015691-2023-15573.H3 other text : discarded at facility.

• Brand Name: FORESIGHT ELITE SENSOR, LARGE
• Type of Device: 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: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 17651210
• MDR Text Key: 322292655
• Report Number: 2015691-2023-15574
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FSESL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other