MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMPUTER, DIAGNOSTIC, PROGRAMMABLE; PRESSURE CONTROLLER

Model Number	PC2K
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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 part of this monthly review.
Event or Problem Description
As reported, this pc2k cable did not reach the expected values.In addition, a hiss could be heard from the module.There was no allegation of patient injury.Patient demographics have been requested.The device was available for evaluation.
Additional Manufacturer Narrative
Finally, the device was not received for evaluation.Without return of the product, a complete investigation of the reported event is unable to be performed.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Based on the available information there is not sufficient evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.Patient demographics unable to be obtained.
Additional Manufacturer Narrative
Added information to section d9, h6 (type of investigation).Updated section h6 (component code) and h6 (investigation findings).Finally, the device was received for evaluation.The reported issue of not reaching the expected values was unable to be confirmed.The pc2k was connected to our known good unit hem1 and no defect was found.When this pc2k was connected to a known working hemosphere system it powered up with no faults to software version 10.2.It was able to give active pressure readings without any leaking noises.Both ports worked as expected.The upper housing had a small crack above the cuff 2 port.No defect was wound concerning the reported issue with the values.Based on the available information there is not sufficient evidence to suggest that the device related issue resulted from incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.The other issue of of physical damage on the housing identified during the device evaluation is most likely related to the handling of the device by the end user.

• Brand Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Common Device Name: PRESSURE CONTROLLER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22803670
• Report Number: 2015691-2025-06635
• Device Sequence Number: 8950790
• Product Code: DQK
• UDI-Device Identifier: 00690103193473
• UDI-Public: (01)00690103193473(17)250603
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2025

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 Expiration Date: 06/03/2025
• Device Model Number: PC2K
• Device Lot Number: 600101032000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/23/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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