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)
Date of Event	06/03/2025
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.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, an acumen adult cuff had fitting issues which caused inaccurate mean arterial pressure (map) measurements.Cuff was applied on the left ring finger and connected to cuff #1, but they could not get a good signal.Finger cuff was measuring a map of 15 to 20 points lower than the brachial non-invasive blood pressure (nibp) on both arms.There were no error messages displayed.Staff tried to reposition and tighten finger cuff but issue could not be resolved.The cuff can only fit the patient's left and right ring fingers due to the other fingers being too large.There were no patient injuries.
Additional Manufacturer Narrative
A product evaluation was completed on the returned cuff.The reported event of "fitting issue" was not able to be confirmed.Finger cuff securely attached to testing finger during pressure test.Width of cuff flex pcb was 62.95mm which met specification 62.93 +/- 0.1mm for model aiqca.The reported event of pressure reading discrepancy was not able to be confirmed.Eeprom verification stated 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 not initiated to assess for any manufacturing related processes since the defect related to "during use - inaccurate values" was not confirmed during product evaluation.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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 22290340
• Report Number: 2015691-2025-04990
• Device Sequence Number: 8466933
• Product Code: DXN
• UDI-Device Identifier: 00690103219067
• UDI-Public: (01)00690103219067(17)261119(11)241119(10)66150647
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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
• Device Model Number: AIQCA
• Device Lot Number: 66150647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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 Age: 38 YR
• Patient Sex: Male
• Patient Weight: 101 KG