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

Model Number EVHRS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2016

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 heart reference sensor (hrs) device did not adjust for height changes.When the hrs was raised above the level of the finger side of the device, the values did not appropriately decrease from zero to a negative number.When the hrs was lowered below the level of the finger side of the device, the values did not appropriately increase to a positive number.There were no error messages observed.The hrs device was being tested.There was no patient involvement.

Manufacturer Narrative

One heart reference sensor (hrs) was received for product evaluation.The heart reference sensor was connected to a known good working clearsight system for testing.The hrs unit did not produce any error messages when tested.It was able to perform zeroing three times without any issues.A normal waveform and normal blood pressure readings were able to be displayed three times without any issues noted.The returned hrs unit was moved around, thus moving the internal flat flex cable and there were no error messages received.A visual inspection was performed and there was no physical damage found.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was not confirmed by evaluation.There are no indications that this is related to the manufacturing process.It could not be determined if any procedural factors may have contributed to the 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 this monthly review.No further actions 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: 6155405
• MDR Text Key: 61862219
• Report Number: 2015691-2016-03618
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: EVHRS
• Device Lot Number: 600104003826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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