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

Model Number	AIQS8
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, this acumen iq sensor was working as expected providing correct vital parameters.However, after a few hours, the sensor started providing inaccurate parameters that were not compatible with life and different from other references that were in the operating room (or).The device was replaced with a new unit and issue was solved.There is no allegation of patient injury.The device was available for evaluation.Patient demographics were unable to be obtained.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.
Event or Problem Description
As reported, after few hours working correctly, this acumen iq sensor provided inaccurate parameters.Other devices in the operating room (or) displayed the correct values.The device was replaced with a new unit and issue was solved.No further information available.There is no allegation of patient injury.Patient demographics were unable to be obtained.
Additional Manufacturer Narrative
The acumen iq sensor involved in this case was received by our product evaluation laboratory for a full evaluation.The report of "inaccurate parameters" was unable to be confirmed.However, as received, disposable pressure transducer sensor of acumen unit did not zero nor sense pressure on pressure monitor.Electrical testing showed that input impedance and output impedance were out of specification.It was observed that soldering material caused a short condition between input and output circuit next to third and fourth solder joints.Acumen sensor of acumen unit zeroed and sensed pressure accurately on pressure monitor.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering evaluation, there are manufacturing controls to avoid potential causes related to the reported malfunction.According to the available information, it could be determined that the root cause is associated to the manufacturing process.The manufacturing personnel was notified to avoid the occurrence of similar events.

• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20026096
• Report Number: 2015691-2024-06255
• Device Sequence Number: 12930341
• Product Code: QAQ
• UDI-Device Identifier: 00690103201086
• UDI-Public: (01)00690103201086(17)250706(11)230707(10)65178997
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 07/06/2025
• Device Model Number: AIQS8
• Device Lot Number: 65178997
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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 Sex: Unknown