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)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a vwca displayed inaccurate blood pressure values during an elective knee surgery.This issue occurred while troubleshooting of another malfunctioned vwca.Staff used a third cuff but issue continued.Staff eventually just stopped using the finger cuffs.The patient did not receive treatment for the inaccurate values.There was no patient harm.
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.A report with fda report id number 2015691-2025-02124 was submitted for the first malfunctioned cuff.A supplemental report will be sent when the fda report id number for the third cuff is available.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
Report with fda report id number 2015691-2025-02148 was submitted for the third malfunctioned vwa.
Additional Manufacturer Narrative
A product evaluation was completed on the returned cuff.The reported pressure reading issue was not able to be confirmed.Finger cuff passed eeprom verification with unused status.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 post-decontamination leak test.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The reported issue could not be confirmed with product evaluation and no product nor process malfunction was identified.Product evaluation identified that this device was unused.A device history record review was completed and documented that device met all specifications upon distribution.As part of the manufacturing process, 100% of the manufactured units go through a visual inspection and electrical test.Per the 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.".

• 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
• 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: 21663816
• Report Number: 2015691-2025-02136
• Device Sequence Number: 12650809
• Product Code: DXN
• UDI-Device Identifier: 00690103218893
• UDI-Public: (01)00690103218893(17)260316(11)240316(10)65617838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 03/16/2026
• Device Model Number: VWCA
• Device Lot Number: 65617838
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 06/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/07/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2024
• 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 Sex: Unknown