MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VITAWAVE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	VWCA2
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	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: dqe, qaq, mud, dxn, dsb, fll, qms, olw.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is completed.An mdr was submitted against the pc1q.A supplemental report will be submitted once the report id 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.
Event or Problem Description
It was reported that, during use, a vitawave cuff with a pc1q was not correlating with the blood pressure cuff.The finger cuff and cable set displayed lower than normal diastolic blood pressures.Both devices were connected to a hemosphere steam.There was no patient harm.It is unknown if the cuff or cable caused the issue.
Additional Manufacturer Narrative
The device was disposed.Without the 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.It is not known if some procedural factors may have contributed to the event.In addition, a device history record cannot be completed without a lot number.Report with fda report id number 2015691-2026-10425 was submitted for the pc1q that was used during the case.

• Brand Name: VITAWAVE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 23891147
• Report Number: 2015691-2025-10592
• Device Sequence Number: 12667876
• Product Code: DQK
• UDI-Device Identifier: 00690103219609
• UDI-Public: 00690103219609
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K243781
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: VWCA2
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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