MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000NI SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EV1000NI

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product a supplemental report will be sent with the investigation results. Receiving and servicing documents from the device history record were reviewed; no related non-conformances were found. No escalation is required. 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.

Event Description

As reported, during use with a patient of this ev1000 ni system, there was a difference of 100mmhg between the pressure value by the clearsight and the value given by the arm cuff. The clearsight value was 50 mmhg while the arm cuff value was 150 mmhg. The expected value was 130-150 mmhg. The patient was not treated based on the inaccurate values. There was no error message displayed. There was no allegation of patient injury. The platform was available for evaluation.

• Brand Name: EV1000NI
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 8872116
• MDR Text Key: 154115260
• Report Number: 2015691-2019-02933
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/09/2020
• Device Model Number: EV1000NI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse