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

Model Number	AIQCS
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	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nurse had an issue with an aiqcs cuff.The cuff was reading a 30-40 maps difference from the patients arm cuff; no error messages were displayed.The arm cuff was on the patients opposite arm.Device is available for return.There was no allegation of patient injury.
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.
Additional Manufacturer Narrative
Our product evaluation lab received on acumen iq finger cuff size small.The customer report of inaccurate values was not able to be confirmed.Finger cuff passed eeprom verification with expired status and patient information.The sensor was reset for pressure test.Finger cuff inflated, 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.The finger cuff sensor passed both pre and post-decontamination leak test.An engineering evaluation was completed 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 is associated to a manufacturing/design defect since the device failure was not able to be confirmed.As part of the manufacturing process, 100% of the units go through visual inspection, electrical testing, and qa sampling inspection.A device history record review was completed and documented that device met all specifications upon distribution.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.

• Brand Name: ACUMEN IQ CUFF
• 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 IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20055866
• Report Number: 2015691-2024-06424
• Device Sequence Number: 15483333
• Product Code: DXN
• UDI-Device Identifier: 00690103203325
• UDI-Public: (01)00690103203325(17)250615(11)230616(10)65079537
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K190130
• 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
• Report Date (Section B): 11/06/2024

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: 06/15/2025
• Device Model Number: AIQCS
• Device Lot Number: 65079537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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