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

Model Number	VWCA
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
Additional Manufacturer Narrative
The device was not returned for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.The lot number was not provided thus a device history record was not reviewed.Per hemosphere operators manual, inaccurate non-invasive measurements can be caused by factors such as excessive variations in blood pressure, poor blood circulation to the fingers, a bent or flattened finger cuff, excessive patient movement of fingers or hands, artifacts and poor signal quality, incorrect placement of finger cuff, position of finger cuff, or finger cuff too loose, and electrosurgical unit interference.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 multiple sites had inaccurate values while using a vita wave finger cuff on patients with high bmi.No additional information was provided.

• Brand Name: VITAWAVE
• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21277253
• Report Number: 2015691-2025-00588
• Device Sequence Number: 18115719
• Product Code: DXN
• UDI-Device Identifier: 00690103218893
• UDI-Public: 00690103218893
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: VWCA
• Was Device Available for Evaluation?: No
• 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: 01/13/2025
• Initial Report FDA Received Date: 01/30/2025
• 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