MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VITAWAVE FINGER CUFF ADULT; 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	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the systolic reading on a vw cuff, lot: 65519028, was consistently higher than a nibp cuff during a case.At the restart of case, it was an average of 10 points.During and towards the end of the case, the systolic value of the vw cuff was 30 points higher than the nibp cuff.It was consistent in both procedures.The diastolic values were 1 to 5 points off.Correlation on trends was good.Waveform trend over time behaved as expected when the patient was stimulated or medication was given.No patient injuries.Cuff was attached to a hemosphere vita monitor and not retained after case.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.However, an investigation was initiated to assess for any manufacturing related processes which could be correlated to the lot number.A supplemental report will be forthcoming when the investigation is complete.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
A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: VITAWAVE FINGER CUFF ADULT
• 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 LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19041818
• Report Number: 2015691-2024-02552
• Device Sequence Number: 15292260
• Product Code: DXN
• UDI-Device Identifier: 00690103218893
• UDI-Public: (01)00690103218893(17)260107(11)240108(10)65519028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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
• Device Expiration Date: 01/07/2026
• Device Model Number: VWCA
• Device Lot Number: 65519028
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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