MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVHRS; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EVHRS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be evaluated; however, at the time of this report, the device has not been returned.A supplemental report will be submitted to communicate the results of the complaint investigation results.

Event Description

It was reported that during a demonstration of the clearsight technology, inaccurate blood pressure values were observed when the hrs was used.The hrs overestimated a high nibp pressure by 20-30 mmhg and underestimated a low nibp by 20-30mmhg.There were no error messages displayed.Exchanging the hrs for another hrs the issue was solved.No patient compromise was reported.No other system-related devices were reported as suspect.Inquired of patient demographics, unable to be obtained.

Manufacturer Narrative

The review of the device history record supports that there were no non-conformances noted for any reason and met all specifications upon distribution.The device is expected to be evaluated; however, at the time of this report, the device has not been returned.A supplemental report will be submitted to communicate the results of the complaint investigation results.

Manufacturer Narrative

Examination of the returned hrs was unable to confirm the customer¿s complaint.No fault was found.The hrs was connected to a clearsight mockup system for testing.The sensor responded appropriately to differences in bladder sensor height.Normal blood pressure readings were obtained three times.No error messages were observed.Bending and flexing of the cable near the hdmi connector did not cause any errors.No physical damage was observed in the visual inspection.No damage was found via x-ray and no oil leakage was found.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.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 this monthly review.No corrective or preventative actions are required with respect to this device.

• Brand Name: CLEARSIGHT EVHRS
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6498922
• MDR Text Key: 73042504
• Report Number: 2015691-2017-01032
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: EVHRS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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