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

Model Number	PC1Q
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, in this target market release (tmr), following patient intubation, this smart pressure controller cable provided a slight discrepancy in blood pressure (bp) of 20mm hg compared to the brachial cuff, which was placed on the same arm (right).Once the patient was on the table, the finger cuff was moved to the left arm, and after a while, values matched up the values provided by the brachial cuff.No error message was displayed.The patient was not treated according to incorrect values.There was no allegation of patient injury.The device was not available for evaluation.
Additional Manufacturer Narrative
An investigation will be performed to consider any potential factors that may have contributed to this complaint and 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.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (investigation findings) and h6 (investigations conclusions).No product was returned for evaluation since the device was part of target market release (tmr).Without return of the product, a complete investigation of the reported event is unable to be performed.Nevertheless, the device logs were provided for evaluation.Based on the log review it could be concluded that the cuff and algorithm itself is behaving as expected; its within reason that due to the brachial cuff being placed on the same arm and going off so frequently that pressure downstream (finger cuff) does not match exactly with the brachial (which also is not the gold standard).The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on the available information there is not sufficient evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 23494801
• Report Number: 2015691-2025-09124
• Device Sequence Number: 15694622
• Product Code: DQK
• UDI-Device Identifier: 00690103219395
• UDI-Public: (01)00690103219395(11)250827
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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
• Device Lot Number: 2020000455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Male