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

Model Number 01-06-3000

Device Problems Incorrect Measurement (1383); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned, but has not arrived.When the evaluation findings are available a supplemental report will be submitted.The device service history record review has not been completed.When the findings are available a supplemental report will be submitted.The submission number for the other product involved in this event will be submitted in the supplemental report.

Event Description

It was reported that during patient monitoring with a foresight elite tissue oximeter monitor and a foresight elite preamp cable that the patient parameter numbers were drifting out of normal range for the patient¿s condition.The clinicians power cycled the monitor and then the numbers displayed within acceptable range.Further information has been attempted to be obtained from the facility, but has been unsuccessful.Patient demographic information has been requested and not received.There was no inappropriate patient treatment reported.There was no patient harm or injury reported.

Manufacturer Narrative

Several attempts were made to request product return and it did not arrive for evaluation.The reported issue could not be confirmed by product evaluation.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.It could not be confirmed if user or procedural factors contributed to the stated event.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.The device service 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.The submission number for the other product involved is 2015691-2020-10843.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FORESIGHT ELITE ABSOLUTE TISSUE OXIMETER
• Type of Device: FORESIGHT ELITE TISSUE OXIMETER MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9801769
• MDR Text Key: 193074950
• Report Number: 2015691-2020-10842
• 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,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: 01-06-3000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1