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	03/08/2024
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.In addition, the lot number was not provided thus a device history record was not reviewed.No corrective actions will be taken at this time.Per the instructions for use it states, do not apply finger cuff or cuffs on a hand or a finger when a second blood pressure measurement device is actively monitoring on the same arm or hand or finger.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 a vw cuff had inaccurate readings during an orthopedic hip procedure.Upon monitoring, values showed wide disparity between vw cuff and brachial cuff values.In the or, the vw cuff readings were in the 60s for systolic while brachial cuff was in the 100s.The pressure reading for the vw cuff remained low during the entire case.During post case, the patient was followed to the pacu.After extubation, the finger cuff pressure values went up.When patient was awake in pacu, a large acumen cuff was put on the patient to test the pressure values.The finger cuff readings matched the brachial cuff values that were being seen during the case.It was noted that the patient has large fingers and that diodes sat low on the finger.Rep reported that it was likely that the vw finger cuff was placed on the same arm as the brachial cuff.Vw cuff was used with a hemosphere vita monitor with serial number (b)(6).Case lasted 3 to 4 hours and occurred on (b)(6) 2024 at 0800.No patient injuries reported.
Additional Manufacturer Narrative
Lot number was previously unknown, but later identified as 65519028 after follow up with representative.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: 18960189
• Report Number: 2015691-2024-02219
• Device Sequence Number: 7051229
• 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): 05/13/2024

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: 03/08/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male