MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE VITA; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	HEMPC2K
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.A device history record review was performed and no related non-conformances were found.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.Product code: product code name.Dsb plethysmograph, impedance.Qms: adjunctive open loop fluid therapy recommender.Dqe: catheter, oximeter, fiber-optic.Dqk: computer, diagnostic, programmable.Mud: oximeter, tissue saturation.Fll: thermometer, electronic, clinical.Qaq: adjunctive predictive cardiovascular indicator.
Event or Problem Description
It was reported that, during use, that the clearsight blood pressure (bp) was inaccurate when compared to the other "cnp blood pressure".The blood pressures continued to drop to 0/0 and then stop.The user re-zeroed the hemosphere pressure controller kit, which temporarily corrected the issue for a few minutes but then the event occurs again.There are no allegations of patient injury or harm.
Additional Manufacturer Narrative
One pressure controller kit was returned for evaluation.The customer report was unable to be confirmed.The hemosphere vita (hempc2k) was connected to an hemosphere alta (altaall1).The ev1000 (pc2k) caused no errors.The connected heart reference sensor successfully zeroed.Normal waveform and bp readings were able to be acquired a on each cuff.Monitored for 1 hour on each cuff and there was no loss of readings or the waveform.No damage was found.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The complaint affected unit was returned for evaluation and no defect was found.Based on the information obtained, the root cause of the alleged complaint is unable to be determined at this time.There was no evidence of product nonconformance or labeling/ifu inadequacies identified.As part of the manufacturing process 100% of the units go through an electrical inspection process.Complaints incidence will continue to be monitored, and applicable actions will be taken as required.

• Brand Name: HEMOSPHERE VITA
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618
• MDR Report Key: 24597848
• Report Number: 2015691-2026-13172
• Device Sequence Number: 15829317
• Product Code: DQK
• UDI-Device Identifier: 00690103217124
• UDI-Public: (01)00690103217124(11)241017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/27/2026

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: HEMPC2K
• Device Catalogue Number: HEMPC2K
• Device Lot Number: 600101044093
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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