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	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during induction, a pc1q while connected to a vitawave plus cuff showed different values compared to an arm cuff.Initially, the finger cuff values were 146/63 (93) while the arm cuff read 165/70 (106).After a few arm adjustments were made and reclipping the pc1q, the finger cuff values were updated to 118/52 (75) and the arm cuff values were 130/55 (80).Patient was undergoing a spine procedure.Both cuffs were not placed on the same arm.It is unknown whether the inaccurate values were caused by the vitawave plus cuff or the pc1q.There were no patient injuries.
Additional Manufacturer Narrative
Additional product code: dqe, qaq, mud, dxn, dsb, fll, qms, olw device is not available for return.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.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Report id: (b)(4) was submitted against the vitawave plus cuff.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.
Additional Manufacturer Narrative
This event was found to be a duplicate of an existing report, 2015691-2025-09143.

• 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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 23660277
• Report Number: 2015691-2025-09614
• Device Sequence Number: 13292951
• Product Code: DQK
• UDI-Device Identifier: 00690103219395
• UDI-Public: 00690103219395
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown