MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR ACUMEN IQ SENSOR; ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR

Model Number	AIQS85
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	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of an acumen iq system a 56-year-old female with an ejection fraction of 60-65% and two vessel disease.The patients stroke volume displayed a high number on the monitor that did not match the clinical picture of the patient.Trouble shooting was attempted to resolve the issue.There was no allegation of patient injury.
Additional Manufacturer Narrative
The pressure sensor is not being returned and the complaint cannot be confirmed without the completion of an evaluation of the suspect device.A supplemental report will be submitted upon the conclusion of the investigation.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without 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.No corrective actions will be taken at this time.Corrections to the h6 investigation findings, and investigation conclusions were made.A device history record review was completed and documented that device met all specifications upon distribution.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: ACUMEN IQ SENSOR
• Common Device Name: ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18387578
• Report Number: 2015691-2023-18665
• Device Sequence Number: 16819174
• Product Code: QAQ
• UDI-Device Identifier: 50690103200947
• UDI-Public: (01)50690103200947(17)250809(11)230810(10)65259121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183646
• 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): 01/31/2024

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 Expiration Date: 08/09/2025
• Device Model Number: AIQS85
• Device Lot Number: 65259121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 56 YR
• Patient Sex: Female