MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA; CATHETER, OXIMETER, FIBER-OPTIC

Model Number	ALTASR1
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	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda product codes: dsb plethysmograph, impedance dxn system, measurement, blood-pressure, non-invasive fll thermometer, electronic, clinical mud oximeter, tissue saturation qaq adjunctive predictive cardiovascular indicator qem cerebral oximeter qms adjunctive open loop fluid therapy recommender qnl medium-term adjunctive predictive cardiovascular indicator dqk computer, diagnostic, programmable the device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not been 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 prior to use, the hemosphere alta system with clearsight displayed a subsystem failure alert.The end user restarted the device and cleared the alert; however, subsequent measurements showed variations in blood pressure (bp) and pulse rate (pr).The issue could not be resolved even after replacing the pc2k module.Additional follow-up efforts have focused on determining patient involvement and whether any injury or harm occurred as a result of the reported event.At this time, no further information has been provided.
Additional Manufacturer Narrative
The device history record review has been completed.No related non-conformances were found.No escalation required.The suspect device was evaluated by our product evaluation and team and the reported event could not be confirmed.As the complaint could not be confirmed the purpose of the root cause analysis is to determine if the device related issue resulted from: incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.Based on the voice of the customer there is not sufficient evidence to suggest that the device related issue resulted from any of the specified factors.

• Brand Name: HEMOSPHERE ALTA
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• 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: 23659549
• Report Number: 2015691-2025-09610
• Device Sequence Number: 10055594
• Product Code: DQE
• UDI-Device Identifier: 00690103217964
• UDI-Public: (01)00690103217964(11)250320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: ALTASR1
• Device Catalogue Number: ALTASR1
• Device Lot Number: 19Y0001587
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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