MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVHRS; NON-INVASIVE HEART REFERENCE SENSOR

Model Number EVHRS

Device Problem Incorrect Measurement (1383)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the investigation results.

Event Description

It was reported that the clearsight heart reference sensor (hrs) unit did not display the correct pressure readings during a training demonstration with rns.The hrs unit displays the pressure values based on the height difference between the heart and the finger to which the cuff is attached.This hrs did not change with height differences, therefore giving inaccurate values.There was no error message noted.The suspect hrs unit was exchanged for a different hrs unit, and the values were as expected.There are no other suspect devices involved.There was no patient involvement.

Manufacturer Narrative

One heart reference sensor was returned for product evaluation.The hrs unit was connected to a known good working clearsight system for analysis and testing.The sensor did not respond appropriately to differences in bladder and sensor height.The hrs unit measures values based on the height differences between the heart and the finger to which the cuff is attached.It takes into account differences in pressure between the finger and heart and compensates hydrostatic pressure changes due to differences in height between the finger and the heart.There were normal blood pressure readings that were obtained three times.The hrs unit failed the ft2 calibration test.A visual inspection of the unit was performed and there was no physical damage found and there was no oil leakage observed.An x-ray was taken and there was no internal damage found.The hrs unit was manufactured may 2016 and has been in the field for approximately ten months.The root cause of the failure is expected wear over normal use.The use life of the hrs unit is stated in the ifu as 90 days.The ifu contains several troubleshooting measures in the event there is a pressure difference, including re-zeroing, verifying hrs placement and replacing the hrs, if necessary.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was confirmed by product evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported event as the stated issue is thought to be expected wear over normal use.The issue will continue to be monitored as part of the monthly management review process.There is no further action that will be taken at this time.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: NON-INVASIVE HEART REFERENCE 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: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6436224
• MDR Text Key: 70990539
• Report Number: 2015691-2017-00792
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Model Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FINGER CUFF