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

Model Number	AIQCA
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned as it was discarded by the hospital.However, a supplemental report will be forthcoming once the engineering evaluation 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 after use of the acumen iq finger cuff, positioned adjacent to a finger with a pulse oximetry sensor, the patient developed a blister on their finger tip.The device is not available for evaluation as it was disposed.There was no other patient injury reported.
Additional Manufacturer Narrative
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 not returned for evaluation, a product non-conformance or device failure associated to manufacturing or design could not be confirmed.The lot number was not provided thus a device history record was not reviewed.The instructions for use contain the following warnings: do not apply the finger cuff on injured skin as this may cause further injury.To reduce the risk of skin irritation and tissue damage, do not monitor longer than 8 hours continuously on a single finger.To continue to monitor beyond 8 hours, use an additional finger cuff on another finger or move the cuff in use to another finger.

• 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 IRVINE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 22487280
• Report Number: 2015691-2025-05656
• Device Sequence Number: 12808036
• Product Code: DXN
• UDI-Device Identifier: 00690103219067
• UDI-Public: 00690103219067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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