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
Event or Problem Description
It was reported that, during use, multiple aiqca cuffs were displaying a map of at least 22 mm hg below the reading from a nibp arm cuff, some were more than 30 mm hg below.There was no patient injury.No patient was treated off of the inaccurate values.Devices are available for return.
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.
Additional Manufacturer Narrative
One adult acumen iq finger cuff was returned for evaluation.The customer 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 zeroed and sensed pressure on hemosphere monitor without any error message.Electrical testing showed that all elements such as shield, led, and photodiode of returned unit were ok.No visible damage was noticed from the returned finger cuff.Finger cuff sensor 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.Since the complaint affected unit was returned for evaluation and no defect was found a product non-conformance or device failure associated to manufacturing or design could not be confirmed.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
Correction required: procode changed from dnx to dxn.

• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22102452
• Report Number: 2015691-2025-04226
• Device Sequence Number: 7156667
• Product Code: DXN
• UDI-Device Identifier: 00690103219067
• UDI-Public: (01)00690103219067(17)261024(11)241024(10)66106648
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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 Model Number: AIQCA
• Device Lot Number: 66106648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 09/08/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown