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

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	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dsb- plethysmograph, impedance dxn- system, measurement, blood-pressure, non-invasive fll- thermometer, electronic, clinical mud- oximeter, tissue saturation qaq- adjunctive predictive cardiovascular indicator 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.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 during use of the alta all in one, an unprompted high-pitched alarm occurred during the case.The touchscreen froze, arterial line pressure disappeared from the anesthesia monitor, and svo2 read approximately 30 points lower than expected.Rebooting the monitor restored function, but the svo2 reading remained inaccurate.There was no patient injury.
Additional Manufacturer Narrative
One hemosphere alta all-on-one monitor was returned for evaluation.The customer report of inaccurate values was not confirmed.Monitored svo2 for an hour.The reading remained steady at 80%.Monitored for 1 hour using clearsight.Readings and waveform were steady the entire time.No errors or alarms occurred.No damage was found.The device history record review was completed and the product passed without nonconformances.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Since there was no defect found, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect and no root cause can be determined.The ifu contains the following precautions: inaccurate cardiac output measurements may be caused by incorrect placement or position of the catheter, anatomical abnormalities, excessive patient movement, or electrocautery or electrosurgical unit interference.

• Brand Name: HEMOSPHERE ALTA
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23352285
• Report Number: 2015691-2025-08706
• Device Sequence Number: 15719927
• Product Code: DQE
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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
• Device Lot Number: 19Y0000346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown