MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES EV1000; PLETHYSMOGRAPH, IMPEDANCE

Model Number	PC2K
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	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: dxn, system, measurement, blood-pressure, non-invasive, dqk, computer, diagnostic, programmable, qaq, adjunctive predictive cardiovascular indicator, dxg, computer, diagnostic, pre-programmed, single-function.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.A device history record review was completed and documented that device met all specifications upon distribution.
Event or Problem Description
It was reported that, during use, the staff noticed a blood pressure (bp) difference between the clearsight and non-invasive blood pressure.The clearsight consistently showed low mean arterial pressure (map) vs.Simultaneous non-invasive blood pressure.It was confirmed that there was no patient harm associated with the reported issue.
Additional Manufacturer Narrative
There was no product evaluation as the device was discarded and not returned.Without its return, it is not possible to determine if there was damage or a defect that existed on the unit that could have contributed to the event.It is not known if any procedural factors may have contributed to the reported issue.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the complaint could not be confirmed, there is not sufficient evidence to determine a root cause.

• Brand Name: EV1000
• Common Device Name: PLETHYSMOGRAPH, IMPEDANCE
• Manufacturer (Section D): EDWARDS LIFE SCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFE SCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22322408
• Report Number: 2015691-2025-05150
• Device Sequence Number: 9023689
• Product Code: DSB
• UDI-Device Identifier: 00690103193473
• UDI-Public: (01)00690103193473(11)230913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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
• Operator of Device: Health Professional
• Device Model Number: PC2K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown