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

Model Number EVHRS

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

The product has been returned for evaluation; however, the evaluation is in progress. Upon receipt of the evaluation results a supplemental report will be submitted. The device history record review was completed and all manufacturing inspections passed with no non-conformances and the product met all specifications upon distribution.

Event Description

It was reported that while the clinician was setting up, prior to patient use, the evhrs unit (heart reference sensor) would not adjust for height changes after zeroing. When the evhrs unit was zeroed the blood pressure reading was appropriate. When the hrs unit was raised above heart level, the blood pressure did not decrease as expected. When the hrs unit was lowered below the heart level, the blood pressure did not increase as expected. There were no error messages observed. The suspect evhrs unit was exchanged for another evhrs unit and the same steps were followed and then the evhrs unit responded appropriately. There was no patient involvement. There was no patient harm or injury.

Manufacturer Narrative

One ev1000ni heart reference sensor was received for product evaluation. The examination found that the evhrs unit was able to perform zeroing in any relative position. When the ft2 functional and calibration tester was performed on the unit, the hrs unit failed the test. An x-ray was performed on the unit and there were multiple breaks found on the internal flat flex cable. The flat flex cable connects the dpt sensor to the printed circuit board internally. The damaged flat flex cable is consistent with the unit having been twisted or strained during use. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. The complaint was confirmed by evaluation. Although the root cause of the damage cannot be conclusively determined, handling factors may have contributed to the issue. The operators manual pn 157811 appendix e states the proper handling of the unit by the user. A corrective and preventive action has been generated to address this issue.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: NON-INVASIVE HEART REFERENCE SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92606
• 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: 5773981
• MDR Text Key: 48923695
• Report Number: 2015691-2016-02155
• 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

• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/01/2017
• Device Model Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown