MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON INVASIVE; ACUMEN IQ FINGER CUFF

Model Number	AIQS6
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is being evaluated.When the product evaluation has been completed the findings will be submitted in a supplemental report.The lot serial number is unknown.When the lot serial number has been obtained, the device history record review will be completed and the results included in a supplemental report.
Event or Problem Description
It was reported that there were inaccurate cardiac index values with the pressure monitoring acumen iq sensor.This occurred during use.The cardiac index value that was displayed was 1.1lmin m2.This was a lower than expected value of 2.0lmin m2.The device was able to be zeroed.There was no abnormal waveform that was observed.There were no error messages that displayed.Any troubleshooting was unable to be performed.The exact occurrence date is not known.The patient demographics was requested but unable to be provided.There was no patient injury reported.
Additional Manufacturer Narrative
The sensor was returned and evaluated.The evaluation found that the report of inaccurate values was not confirmed.There were no error messages noted.The acumen sensor zeroed and sensed pressure accurately on the hemosphere and pressure monitor.The pressure reading did not drift during the output drift testing.Electrical testing found that both input and output impedance were within specifications.No visible inconsistency was observed from the unit.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.As part of the manufacturing process, current risk mitigations include 100 percent visual inspection by manufacturing, 100 percent electrical testing and continuous monitoring sampling.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 lot number was not obtained, therefore, the device history record review could not be completed.

• Brand Name: SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON INVASIVE
• Common Device Name: ACUMEN IQ FINGER CUFF
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; parque industrial de itabo; carr sanchez km18.5, dominican republic
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 19822968
• Report Number: 2015691-2024-05633
• Device Sequence Number: 21055602
• Product Code: DXN
• UDI-Device Identifier: 00690103201178
• UDI-Public: (01)00690103201178
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: AIQS6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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