MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000A PLATFORM SYSTEM

Model Number	EV1000A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the biomed that there were fluctuating and incorrect values with the ev1000 system.When they exchanged the suspect ev1000 system for another one, then the issue was resolved.There were no error messages present.There was no inappropriate patient treatment reported.The patient demographics has been requested, but not provided.Several attempts have been made to the facility for additional details and no response received.There was no patient harm or injury.
Additional Manufacturer Narrative
The product has been requested to be returned for evaluation, but has not yet arrived.Once it has arrived and the evaluation completed a supplemental report will be submitted with the evaluation findings.The device service history record review was completed and all manufacturing inspections passed with no non conformances.
Additional Manufacturer Narrative
Product return requests were sent to the customer and no response was received.The device was not returned.If the product arrives and an evaluation is completed, a supplemental report will be submitted with the findings.H3 other text: product not received.
Additional Manufacturer Narrative
The suspect ev1000 system was evaluated.When the panel and databox were connected to a patient simulator for testing, the ap and cvp was able to be zeroed appropriately with no error messages noted.The panel was set to monitor the cardiac output, the cardiac input and the stroke volume.The readings obtained were steady with no fluctuations.It was left to run for over three hours and there was still no fluctuation in the readings.There was no defect found.

• Brand Name: EV1000A PLATFORM SYSTEM
• Common Device Name: EV1000A PLATFORM SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13673390
• Report Number: 2015691-2022-04272
• Device Sequence Number: 14778017
• Product Code: DXG
• UDI-Device Identifier: 00690103189650
• UDI-Public: (01)00690103189650(11)170312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: EV1000A
• Device Catalogue Number: EV1000A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 05/03/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/16/2022; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown