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	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: dqe, dsb, dxn, fll, mud, qms, qnl, dqk.Additional fda 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.In addition, a device history record cannot be completed without a serial number.If the device is returned, a supplemental report will be submitted.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, the blood pressure (bp) readings obtained from an alta monitor were inconsistent and not correlating with the non-invasive blood pressure cuff or invasive arterial line.Mean arterial pressure (map) values, systolic, and diastolic values were often vastly inaccurate, either much higher or lower.Per representative, "this discrepancy has occurred repeatedly several times per day across multiple cases and appears to resolve only when the patient monitor is zeroed before acumen iq finger cuff application." there were no allegations of patient injuries.Issue occurred at other hospitals.Further information was not provided.It is unknown how many hospitals and monitors were affected.

• 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 92618 ; 9492017706
• MDR Report Key: 23589476
• Report Number: 2015691-2025-09382
• Device Sequence Number: 10159918
• Product Code: QAQ
• UDI-Device Identifier: 00690103217957
• UDI-Public: 00690103217957
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/18/2025

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
• Was Device Available for Evaluation?: No
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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