MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE ABSOLUTE TISSUE OXIMETER; FSE MONITOR

Model Number 01-06-3000

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

One foresight elite absolute tissue oximeter was received for product evaluation.The device was powered up and attached to two elite preamp simulators for testing.During testing, channel 2 reported an st02 value at 70%.This was a reading higher than the expected value of 60%.A known working nsam board was installed and replaced the suspect board within the device.The device was re-tested and the channel 2 values read as normal and as expected.There were no error messages observed.There were other components that were replaced within the device as per procedure.The root cause was determined to be nsam board failure.These results were identified within the product evaluation investigation and not in a clinical setting.The device history record review was completed and all manufacturing inspections passed with no non-conformances.The record of servicing has been reviewed and there is no previous related record.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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 the monthly review.

Event Description

It was reported that the foresight elite absolute tissue oximeter monitor gave a message of "sensor overtemp" display.They exchanged the sensors and received the same notification.They exchanged the suspect fse monitor for another one, using the same cables and then the issue was resolved.This was during use.There is no patient injury.

Manufacturer Narrative

Additional testing was performed on the returned fse tissue oximeter.The results are that when the suspect nsam board was placed in a known good working unit for testing and then placed back in the suspect unit, the failure was not observed.The failure is likely related to a loose connection between the board/cable, but it cannot be confirmed as the inaccurate st02 values were no longer present during further testing.The error message of "sensor overtemp" that was reported by the customer could not be tested as it could not be replicated during testing.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint.

• Brand Name: FORESIGHT ELITE ABSOLUTE TISSUE OXIMETER
• Type of Device: FSE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11197930
• MDR Text Key: 232590267
• Report Number: 2015691-2021-00205
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• PMA/PMN Number: K143675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Model Number: 01-06-3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CABLES