Edwards EV1000A

2 of 3
• Another opportunity for liquid ingress into the power supply could be the cleaning and
disinfection process. Although the cleaning instructions in the EV1000 Operators Manual
indicate both to only wipe with a damp cloth and to dry the cable after cleaning, user reports
indicate that this process is not always followed.
• Please assure that the cleaning instructions as noted in the EV1000 Operators Manual are
followed, and that the AC power cord and inlet are clean and dry prior to use.
Edwards is working to address all of the root causes, and to implement actions on units already in
the field as quickly as possible.
These actions include:
 Updated customer notification of all potential causes and mitigations, including ensuring the
AC power cord and inlet are kept clean, dry and free of contamination by conductive materials
prior to use. (completed with this notification).
 Updating the Operators Manual to include the instructions as noted above and any others
identified as our investigation continues (in progress).
 Visiting your facility to (1) apply a label to the AC power cord to help assure proper orientation
to avoid liquid ingress, and (2) confirm that the area is clear of potential contaminants.
 Implementation of design changes that would eliminate or reduce the potential for liquid ingress
and other potential contaminants (identification in progress).
This notice needs to be passed on all those who need to be aware within your organization or to
any organization where the potentially affected devices have been transferred.
If you have any questions, please contact Edwards Customer Service or Tech Support at
<phone>
Sincerely,
Vice President of Quality, Critical Care
This Urgent Field Safety Notice has been communicated by Edwards Lifesciences to the relevant
competent authority.