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

Model Number	AIQCA
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 evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record review has not yet been completed.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 of the acumen cuff it displayed a map value approximately 20-30 mm hg lower than expected when compared to the nibp.Troubleshooting did not resolve this issue.There was no treatment provided based on inaccurate values and no patient injury.
Additional Manufacturer Narrative
One adult acumen iq finger cuff was returned for evaluation.The customer report of inaccurate pressure reading was not confirmed.The finger cuff did not function on hemosphere monitor.Finger cuff passed eeprom verification with expired status and patient information.Finger cuff was reset for pressure test.Finger cuff failed pressure test on hemosphere monitor with error message "fault: finger cuff #1 or finger cuff connector error".Clearsight cuff tester did not recognize finger cuff during electrical testing.The flex pcb was found completely torn near the edge of the solder.No other visible damage was observed from the finger cuff.Finger cuff passed both pre- and post-decontamination leak test.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode of inaccurate values is associated to a manufacturing/design defect.The instructions for use contains the following warnings: improper placement, sizing, or alignment of the finger cuff can lead to inaccurate monitoring.Do not apply finger cuff(s) on a hand or finger when a second blood pressure measurement device is actively monitoring on the same arm (or hand or finger).As part of the manufacturing process 100% of the units go through an electrical testing, visual inspection, and qa sampling inspection.A device history record review was completed and documented that device met all specifications upon distribution.
Additional Manufacturer Narrative
One adult acumen iq finger cuff was returned for evaluation.The customer report of pressure reading issue was confirmed, however the report of inaccurate values was unable to be confirmed.Finger cuff passed eeprom verification with expired status and patient information.Finger cuff was reset for pressure test.Finger cuff failed pressure test on hemosphere monitor with error message "fault: finger cuff #1 or finger cuff connector error".Clearsight cuff tester did not recognize finger cuff during electrical testing.The flex pcb was found completely torn near the edge of the solder.No other visible damage was observed from the finger cuff.Finger cuff passed both pre and post-decontamination leak test.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode of inaccurate values is associated to a manufacturing/design defect.The instructions for use contains the following warnings: improper placement, sizing, or alignment of the finger cuff can lead to inaccurate monitoring.Do not apply finger cuff(s) on a hand or finger when a second blood pressure measurement device is actively monitoring on the same arm (or hand or finger).As part of the manufacturing process 100% of the units go through an electrical testing, visual inspection, and qa sampling inspection.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: ACUMEN IQ CUFF ADULT
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• 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 ; 9492503939
• MDR Report Key: 22102394
• Report Number: 2015691-2025-04222
• Device Sequence Number: 7356208
• Product Code: DXN
• UDI-Device Identifier: 00690103219067
• UDI-Public: (01)00690103219067(17)261001(11)241001(10)66041514
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2026
• Device Model Number: AIQCA
• Device Lot Number: 66041514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 08/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/18/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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