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	06/24/2025
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.No steps were taken intra-operatively to treat the blister.There was no other patient injury reported.
Additional Manufacturer Narrative
It was previously reported that the device was not available for return.However, a the cuff was returned and a product evaluation was completed.The reported event of "patient developed a blister" was confirmed from customer photo.Customer photo showed blister on the tip of middle finger.No visible damage was observed from returned finger cuff during the pre-decontamination evaluation.The bladder appeared intact.The bladder portions on top of the led and pd sensor also appeared intact.No visible contamination was noticed on surface of the bladder.There was no visible damage or contamination on the gold fingers of the finger cuff connector.Electrical testing showed that all elements such as shield, led, and pd of returned unit were ok.Finger cuff passed pre-decontamination pressure decay leak test.In post-decontamination evaluation, finger cuff passed eeprom verification with expired status.The sensor 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 unit.Finger cuff sensor passed post-decontamination leak test.The device history record review was completed and the product passed without nonconformances.Further investigation for this device is not required as no defect was found during product evaluation.

• 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 ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22547140
• Report Number: 2015691-2025-05880
• Device Sequence Number: 7013687
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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