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

Model Number	PC1Q
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	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes include: dqe, catheter, oximeter, fiber-optic.Qaq, adjunctive predictive cardiovascular indicator.Mud, oximeter, tissue saturation.Dxn, system, measurement, blood-pressure, non-invasive.Dsb, plethysmograph, impedance.Fll, continuous measurement thermometer.Qms, adjunctive open loop fluid therapy recommender.Olw, index-generating electroencephalograph software.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record review was not completed as the serial number was not provided.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 or Problem Description
As reported during use in a hemosphere stream tmr the smart pressure controller was not correlating with the blood pressure cuff values.No additional information was available.There was no patient injury.It is unknown if the device will be available for evaluation.
Additional Manufacturer Narrative
Multiple attempts were made to secure the return of the device as well as data logs.However the device was not sent back for evaluation.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.The device history record review was not completed as the serial number was not provided.

• Brand Name: SMART PRESSURE CONTROLLER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 24080776
• Report Number: 2015691-2026-10425
• Device Sequence Number: 17596250
• Product Code: DQK
• UDI-Device Identifier: 00690103219395
• UDI-Public: 00690103219395
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K243781
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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 Model Number: PC1Q
• Was Device Available for Evaluation?: No
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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