MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES HEMOSPHERE ALTA; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, the hemosphere alta monitor experienced significant mean arterial pressure (map) variability when using clearsight.Specifically, arterial line correlation drifting by 20 to 40 mmhg.It was also noted that the suspect device experienced fault: clearsight system air supply error and insufficient pressure build up.There are no allegations of patient injury or harm.
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 been completed.No related non-conformances were found.No escalation required.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.
Additional Manufacturer Narrative
One hemosphere alta was returned for evaluation.The customer report was unable to be confirmed.The unit was monitored using clearsight technology for two hours and the fault: clearsight system air supply error, insufficient pressure build up error never displayed.The map and bp readings were accurate and stable for the entire two hours.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.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 voc there is not sufficient evidence to suggest that the device related issue resulted from any of the specified factors.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 ALTA
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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
• MDR Report Key: 24328911
• Report Number: 2015691-2026-11064
• Device Sequence Number: 13263240
• Product Code: DQK
• UDI-Device Identifier: 00690103217964
• UDI-Public: (01)00690103217964(11)241118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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
• Operator of Device: Health Professional
• Device Model Number: ALTASR1
• Device Catalogue Number: ALTASR1
• Device Lot Number: 19Y0000392
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 04/26/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown