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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.In addition, a device history record cannot be completed without a serial number.No corrective actions will be taken at this time.Report with fda report id: 2015691-2025-10591 was submitted for the vitawave cuff that was used during the case.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
It was reported that, during use, a vitawave cuff had inaccurate readings while connected to a vita monitor and pc1q cable in a ep pfa case.The vitawave plus cuff was placed on the patient's middle right finger.The non invasive blood pressure cuff (nibp) was reading systolic/diastolic in the 180/110 while the finger cuff was reading lower, particularly the diastolic producing a map that was 30 mmhg lower than the nipb.There were moderate vasoconstriction warnings.The cuff was then placed on the ring finger and restarted.The physical reached 60-70 however the sqi was 1 bar for some time.Towards the end of the case, the finger cuff eventually correlated better to the systolic but the diastolic was still lower with the map off by 10-15mmhg.Finger cuff was not placed on the same arm as the nibp.Nibp cuff was set to do readings every 5 then 3 due to discrepancy.Clinicians treated to the brachial arm cuff.It is unknown whether issue was caused by the finger cuff or pc1q cable.

• 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: 23891222
• Report Number: 2015691-2025-10597
• Device Sequence Number: 5344476
• Product Code: DQK
• UDI-Device Identifier: 00690103219395
• UDI-Public: 00690103219395
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/25/2025

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
• 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: 12/16/2025
• Initial Report FDA Received Date: 12/24/2025
• 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