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
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.Report with fda report id number 2015691-2025-02124 and 2015691-2025-02136 were submitted for the two other malfunctioned vwa.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 a vwca displayed inaccurate blood pressure values during an elective knee surgery this issue occurred while troubleshooting of two other malfunctioned vwca.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
Related report numbers 2015691-2025-02124 and 2015691-2025-02136 were previously not written in h10.
Additional Manufacturer Narrative
Multiple attempts were made to secure return of the device however the device was not sent back 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.Manufacturing controls to avoid potential causes of inaccurate values, include visual inspections and electrical testing of 100% of devices.The device history record review was completed and no related non-conformances were found.The instructions for use (ifu) provides the following warnings: do not apply finger cuff(s) on a hand or finger when a second blood pressure measurement device is actively monitoring on the same arm.Do not use a damaged finger cuff.This may result in inaccurate measurements or may damage the edwards monitoring system.Improper placement or alignment of the finger cuff can lead to inaccurate monitoring.

• 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: 21664347
• Report Number: 2015691-2025-02148
• Device Sequence Number: 15434396
• 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): 05/10/2025

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?: 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: 02/27/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 05/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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