MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VIGILANCE II CCO-SV02 CEDV MONITOR; CC MONITOR VIG2

Model Number VIG2

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

The product is not expected to be returned as the hospital does not want to send the monitor back.Without return of the product, it is not possible to determine if damages or defects existed on the product.No actions will be taken at this time.The device history record review was completed and all manufacturing inspections passed with no non-conformances.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this event.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 Description

It was reported that the vigilance ii monitor was being used for patient monitoring when the cco reading was found to be drifting.The values ranged from 1 to 4.There were no error messages noted.The cco cable was tested and passed the cable test, it was eliminated as suspect.The exact occurrence date is unknown.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information is unknown.There is no further information available.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: VIGILANCE II CCO-SV02 CEDV MONITOR
• Type of Device: CC MONITOR VIG2
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8162009
• MDR Text Key: 131380853
• Report Number: 2015691-2018-05260
• Device Sequence Number: 1
• Product Code: DXG
• Combination Product (y/n): N
• PMA/PMN Number: K043103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2014
• Device Model Number: VIG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1