MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA; ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR

Model Number	ALTAALL1
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during use, an alta monitor displayed inaccurate cardiac output, stroke volume, central venous pressure, sto2, and systemic vascular resistance values.The monitor alerts were not audible even though it was activated in the settings and no alerts were displayed.Issue was resolved by restarting the monitor.There were no allegation of patient injuries.Patient demographics are not available.Further information is not available.
Additional Manufacturer Narrative
Additional product code: dqe, dsb, dxn, fll, mud, qms, qnl, dqk additional premarket submission: k242451 it is not known if the device will be returned.Without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.However, an investigation was initiated to assess for any manufacturing related processes which could be correlated to the serial number.A supplemental report will be forthcoming when the investigation is complete.Product evaluation will be included in the supplemental report if device is returned.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.

• Brand Name: HEMOSPHERE ALTA
• Common Device Name: ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92614 ; 9492017706
• MDR Report Key: 22856503
• Report Number: 2015691-2025-06864
• Device Sequence Number: 13008550
• Product Code: QAQ
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240903
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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
• Device Model Number: ALTAALL1
• Device Lot Number: 19Y0000218
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown