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

Model Number EVPMP

Device Problem Incorrect Measurement (1383)

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

Event Date 04/09/2021

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.A device history record review was completed and documented that the device met all specifications upon distribution.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

It was reported that, during preventative maintenance, while performing the functional test, the pressure measurement was out of range showing 217.86mmhg, for cuff 1 300mmhg (with a range of 297.8 to 302.20mmhg).There was no patient involvement.

Manufacturer Narrative

The product was returned for evaluation following preventative maintenance.The reported nonconformance was not confirmed.The pump unit was connected to a piek 3 clearsight hot mockup system.There were no errors messages observed.It was possible to zero the hrs and obtain normal bp readings and waveform.The functional tests were performed, and the device passed all the tests.There was no physical damage that a part had to be replaced.This event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: EV1000 PUMP UNIT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11770304
• MDR Text Key: 248830686
• Report Number: 2015691-2021-02778
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/09/2021
• Device Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1