MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ALTACR1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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, during use this hemosphere alta monitor with a swan ganz catheter, unstable central venous pressure (cvp) was provided (see images attached).In addition, ventricular stroke volume index (vtdi) was not provided.As per customers opinion the issue was caused by the catheter not being positioned correctly.The patient was not in atrial fibrillation and did not have any arrhythmias.No further information is available.There was no allegation of patient injury.
Additional Manufacturer Narrative
Addition to section h6 (type of investigation).Updated section h6 (investigation findings and investigation conclusions).Patient demographics unable to be obtained.No product was returned for evaluation.Without return of the product, it is not possible to perform a complete investigation of the reported event.However, images were provided for review.The report of an unstable cvp value could not be confirmed based on the provided images, as value stability can not be determined from a single still image.However, the displayed value range and image indicated that the cvp could not be within the range.The report of vtdi value not displayed was confirmed based on the provided images.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.Based on further investigation, since the product was not returned for evaluation, the root cause of this event could not be determined.There was no evidence of product nonconformance or labeling/ifu inadequacies identified.

• Brand Name: HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 ; 9492017706
• MDR Report Key: 24466644
• Report Number: 2015691-2026-11587
• Device Sequence Number: 15848238
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K252533
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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: ALTACR1
• Device Lot Number: 19Y0000832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/11/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown