MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVHRS; NON_INVASIVE HEART REFERENCE SENSOR

Model Number EVHRS

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned.The serial number is unknown.The disposition of the device is unknown.Without return of the product, it is not possible to determine if damages or defects existed on the product.No further actions will be taken at this time.The device history record review could not be completed as the serial number is unknown.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the user on these above stated factors that can lead to inaccurate values.It is unknown whether any user or procedural factors contributed in this 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 a part of the monthly review.

Event Description

It was reported that there were inaccurate clearsight map readings during patient monitoring.The readings were off by 10 ¿ 20 mmhg.It is unknown what the clearsight map readings were being referenced against.The issue was isolated to a new heart reference sensor device.The other clearsight components were not considered suspect.The patient demographic information and type of surgery performed are unknown.There was no patient harm or injury.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: NON_INVASIVE HEART REFERENCE SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8479870
• MDR Text Key: 141041778
• Report Number: 2015691-2019-01160
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVHRS
• Device Catalogue Number: EVHRS
• 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