MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000A; COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Model Number EV1000A

Device Problem Incorrect Measurement (1383)

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

Event Date 06/23/2021

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.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 in patient of this clearsight, the mean arterial pressure values provided were approximately 10-15mmhg different from the brachial nibp (non-invasive blood pressure).In addition, the clearsight blood pressure values were increasing while those of the nibp were decreasing and vice versa.No error message was displayed and there was no allegation of cuff malfunction.It was unknown whether the brachial nibp was placed on the same arm as the clearsight.There was no allegation of patient harm.Further information including patient demographics were requested but could not be provided.

Manufacturer Narrative

It was confirmed that this monitor will not be returned for evaluation as it is still used by the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.

• Brand Name: EV1000A
• Type of Device: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12211615
• MDR Text Key: 262959848
• Report Number: 2015691-2021-04283
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K131892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EV1000A
• Device Catalogue Number: EV1000A
• Device Lot Number: EV055538
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRACHIAL NIBP; BRACHIAL NIBP