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	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, a hemosphere stream module with a pc1q had a performance discrepancy compared to a vita monitor.At the start of the case, the stream module with pc1q had a reading of 67/43 (51), the vita monitor with pc2k had a reading of 60/46 (52) and the non-invasive blood pressure cuff (nibp) had a reading of 89/66 (74).After 10 minutes, the table was raised and the procedure started.At this time, the stream module with pc1q had a reading of 94/53 (70), the vita monitor with pc2k had a reading of 105/64 (83) and the non-invasive blood pressure cuff (nibp) had a reading of 127/90 (99).The hs stream continued to show a map difference of 18 to 20 mmhg compared to the vita throughout the case while the vita monitor trended closer to the nibp.Nibp was consistent throughout the entire case.Stream sqi was between 3 to 4 and the vita was 4.The vita monitor was set up on the right index finger with the hrs clip at about 4 inches.The stream monitor was placed on the right ringer finger.Physician treated to the vita monitor and nibp.Due to the value difference, the clinician did not trust the stream module with pc1q.It was noted that the patient's hand appeared curled after the draping was removed, but there were no patient injuries.
Additional Manufacturer Narrative
Additional product code: dqe, qaq, mud, dxn, dsb, fll, qms, olw.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.An mdr was submitted against the hemosphere stream module.A supplemental report will be submitted once the report id is available.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
Report with fda report id number 2015691-2025-10598 was submitted for the hemosphere stream module that was used during the case.
Additional Manufacturer Narrative
Multiple attempts were made to secure the return of the device.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 completed and the product passed without nonconformances.

• 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: 23891208
• Report Number: 2015691-2025-10596
• Device Sequence Number: 7732194
• Product Code: DQK
• UDI-Device Identifier: 00690103219395
• UDI-Public: (01)00690103219395(11)250911
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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
• Device Lot Number: 2020000497
• Was Device Available for Evaluation?: Yes
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 12/24/2025; 02/11/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 12/26/2025; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown