FDA Recall Terminated

Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614

Recall: Z-0262-2008 · Initiated May 17, 2007

Recall

Recall Number: Z-0262-2008
Event Number: 45464
Firm: Edwards Lifesciences, Llc
FEI Number: 2015691
Product Code: DXG
Status: Terminated
Root Cause: Software design
Initiated: May 17, 2007
Posted: November 24, 2007
Terminated: October 9, 2009
Address: 1 Edwards Way, Irvine, CA, 92614-5688

Description

Reason

MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of various patient parameters such as SVR,

Action

An Urgent Customer notification letter dated May 17, 2007 was mailed to all Vigilance II customers advising that If they are "slaving" mean arterial pressure (MAP) from their bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), to be aware that at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25 mmHg. Since the MAP is used in calculations of various patient parameters such as SVR, these may also not be accurate. A table is provided showing those bedside monitors with the problem: GE Solar, Phillips (HP) M1006A, M1006B, as well as, those bedside monitors verified to not have the problem: SpaceLabs Model 90402 and Nihon Kohden Model BSM 8000. The letter also serves to remind the customer of the Warning in the Vigilance II Directions for Use which is also provided in the letter that instructs user to verify slaved MAP values with those displayed on bedside monitor. A temporary work around for this offset problem is to manually enter the MAP based on the readings from the bedside monitor. All Vigilance II calculations from the MAP have been re-verified to be correct when the MAP is accurate. The problem is in the transfer of the MAP between the bedside monitor and the Vigilance II. Customers are also advised that if they have the GE Solar or the Phillips (HP) models listed in the letter or any monitor not listed as verified to be compatible with the Vigilance II (Space labs and Nihon Kohden models listed above) Edwards recommends verification of MAP accuracy prior to treating based on parameters from a Vigilance II in a "slave" configuration. If there is a difference, they should enter the MAP into the Vigilance II manually for a static calculation of SVR. Edwards will be supplying a software update to correct this problem.

Distribution

Worldwide: USA and Canada

Quantity

2,680 units in North America distribution