MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA ADVANCED; ALTA MONITOR

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	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a failure with the alta monitor.The monitor reported 100/100 on the arterial line after the acumen cuff pressure release, this was during patient monitoring.This occurred during a target marketing release at a facility.All parameters were reporting accurately at that point.The physician attempted to stop and restart clearsight monitoring.But after stopping, the clinician could not restart due to the zeroing requirement.They attempted to re-zero, but could not due to heart reference sensor zeroing step.They were seeing the clearsight cuff zeroing.There was no patient harm or injury.
Additional Manufacturer Narrative
The alta unit has not arrived for evaluation.Once it has arrived and the product evaluation results are available a supplemental report will be submitted.The device history record review is pending.Once completed the results will be submitted in a supplemental submission.
Additional Manufacturer Narrative
The unit was not received for product evaluation.The log files were received for review.The log file investigation found that there was no indication of the inaccurate values for the aiq cuff after the cuff release or any indication of the heart reference sensor not zeroing after the cuff release.The scenario was attempted to be re-created but was unsuccessful in reproducing the issue.There was no defect identified.The engineering evaluation was completed.Since the issue was not confirmed, there is not sufficient evidence to determine if this complaint was related to manufacturing, design, or labeling.It is not known if any procedural factors may have contributed to the event.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.The device history record review was completed and all manufacturing inspections passed with no non conformances.

• Brand Name: HEMOSPHERE ALTA ADVANCED
• Common Device Name: ALTA MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19721530
• Report Number: 2015691-2024-05265
• Device Sequence Number: 8206595
• Product Code: DQK
• UDI-Device Identifier: 00690103217704
• UDI-Public: (01)00690103217704(17)20281227
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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