MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMPUTER, DIAGNOSTIC, PROGRAMMABLE; PRESSURE CONTROLLER

Model Number	PC2K
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a demonstration, this pc2k provided incorrect cardiac output (co), stroke volume variation (svv) and systemic vascular resistant (svr) values.Also, hypotension prediction index (hpi) was constantly alerting.There was no error message displayed.There was no patient involved.
Additional 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.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.
Additional Manufacturer Narrative
Updated section h6 (impactcode, type of investigation, investigation findings and investigation conclusions).The pressure controller was received by the original manufacturer for a full evaluation.The reported issue was not confirmed.As received, this pc2k (pressure controller) was connected to a hemosphere hot mockup system.The connected hrs successfully zeroed.The pc2k caused no errors and was able to acquire a normal waveform and bp (blood pressure) readings on both cuff ports.Finally no damage was found on the returned device.Based on further investigation completed by the engineers, the root cause of the issue could not be determine, since no defect was found on the returned device.Based on the available information, no further action is required at this time; however, all events will continue to be reviewed and monitored.

• Brand Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Common Device Name: PRESSURE CONTROLLER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21544383
• Report Number: 2015691-2025-01584
• Device Sequence Number: 20845848
• Product Code: DQK
• UDI-Device Identifier: 00690103193473
• UDI-Public: 0100690103193473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: Other
• Device Model Number: PC2K
• Device Lot Number: 600101035388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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