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UPDATE TO URGENT FIELD SAFETY NOTICE
FCA #128
Product: EV1000 clinical platform
Model Numbers: EV1000A, EV1000NI
Serial Numbers: All serial number for models listed
ACTION REQUIRED
<MM DD, YYYY>
<Customer #>
<Contact name or Dept.>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Dear Valued Customer:
This letter is in follow-up to our previous communications regarding EV1000 monitors and the risk
associated with the power supply as communicated earlier.
Edwards is working to address all the root causes, and to implement corrective and preventative
actions as quickly as possible. There are two types of monitors, each with different power supply
configurations and different actions, as described below.
Edwards would like to highlight the importance of:
EV1000A
The EV1000A utilizes the FloTrac sensor and is powered by an external power supply. As
previously noted, it is important that the “brick” of the power supply always be oriented correctly
to avoid the risk of liquid ingress as shown below and according to the equipment operators’
manual.
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