MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE 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	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: 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.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 set up of the pressure controller kit, it was giving inconsistent readings.The rep exchanged the device for a new one and the issue resolved.There was no patient injury.
Additional Manufacturer Narrative
One hemosphere pressure controller was returned for evaluation.The customer report of inaccurate values was not confirmed.The device was connected to a known working hemosphere system and monitored a cuff simulator for over an hour.The readings were accurate and consistent.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Since the complaint affected unit was returned for evaluation and no defect was found, a product non-conformance or device failure associated to manufacturing or design could not be confirmed.The instructions for use states provides the following warnings and precautions: do not overtighten the pressure controller band.Do not apply pressure controller band on injured skin as this can cause further injury.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: EV1000
• Common Device Name: PLETHYSMOGRAPH, IMPEDANCE
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22136725
• Report Number: 2015691-2025-04388
• Device Sequence Number: 12527776
• Product Code: DSB
• UDI-Device Identifier: 00690103193473
• UDI-Public: (01)00690103193473(11)230726
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/17/2025

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
• Device Lot Number: 600101039403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown