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

Model Number	ALTAALL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, n non-pulsatile mode with this hemosphere alta monitor during this target market release (tmr), cerebral adaptative index (cai) tile was inaccurate since it was not updated with the live map value, even if the live map value was correctly displayed on the monitor.There was no alarm nor error message displayed.There was no allegation of patient injury.There will be no product return as this is a tmr.
Additional Manufacturer Narrative
The product is not expected to be returned for analysis.An investigation will be completed to consider any potential factors that may have contributed to this complaint and 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.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the serial number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Investigation identified that this issue was caused by a software defect in the skynet main gui (v2.0.5) software which is part of alta 2.0 monitor.Product risk assessment was initiated.

• 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 ; 9492503939
• MDR Report Key: 20746358
• Report Number: 2015691-2024-08787
• Device Sequence Number: 8648453
• Product Code: DQK
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240904
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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 Model Number: ALTAALL1
• Was Device Available for Evaluation?: No
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown