MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 PLATFORM; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EV1000A

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.During the evaluation the ev1000a system failed the cvp accuracy test for accuracy at 50mmhg.The range of tolerance is from 49.50 to 50.50 mmhg and the measured value was 46.80 mmhg.After calibration, the problem remained the same.The problem was solved by replacing the iso board.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated and completed to assess for any manufacturing-related processes which could be correlated to the complaint.No manufacturing non-conformances were found.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.In this event the ev1000a system failed the cvp accuracy test when being tested which could lead to inaccurate values if the device was used on a patient.In this case there was no patient involvement.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 a part of the monthly review.

Event Description

As reported, when trying to connect to patient, this ev1000 monitor did not show values.It was turned off and then turned back on for troubleshooting.The error message "ev1000 system failure: ev1000 system fatal exception occurred" was displayed making it unable to continue.There was no allegation of patient injury.There was no patient involved.The device was returned for evaluation.During the evaluation it was found that the device failed the cvp accuracy test.There were no error messages displayed.

• Brand Name: EV1000 PLATFORM
• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 11426448
• MDR Text Key: 245466128
• Report Number: 2015691-2021-01716
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K203131
• 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
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: EV1000A
• Device Catalogue Number: EV1000A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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