MAUDE Adverse Event Report: Edwards Lifesciences IRV CLEARSIGHT MODULE; Computer, Diagnostic, Programmable

Model Number	HEMCSM10
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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the clearsight module the user kept getting inaccurate readings.
Additional Manufacturer Narrative
Additional fda product codes include: dqe- catheter, oximeter, fiber-optic.Qaq- adjunctive predictive cardiovascular indicator.Mud- oximeter, tissue saturation.Dsb- plethysmograph, impedance.Qms- adjunctive open loop fluid therapy recommender.Fll- thermometer, electronic, clinical.Dxn- system, measurement, blood-pressure, non-invasive.Olw- index-generating electroencephalograph software.The device is not expected to 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.An engineering evaluation will be initiated to assess for any manufacturing related processes which could be correlated to the reported lot number.A supplemental report will be forthcoming when the investigation is completed.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.

• Brand Name: CLEARSIGHT MODULE
• Common Device Name: Computer, Diagnostic, Programmable
• Manufacturer (Section D): Edwards Lifesciences IRV; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; +1(949)201-7706
• MDR Report Key: 50774306
• Report Number: 2015691-2026-18566
• Device Sequence Number: 16056466
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: 00690103202762
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: HEMCSM10
• 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: 08/26/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown