Edwards EV1000A User Manual

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URGENT FIELD SAFETY NOTICE –
FCA #128
EV1000
Model Numbers: EV1000A, EV1000NI
Lot Numbers: All lots for models listed
<MM DD, YYYY>
<Customer #>
<Contact name or Dept.>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Dear Valued Customer:
As part of our strong commitment to quality, we continuously monitor our products throughout
their life cycle to quickly identify and correct any potential issues. We recently became aware of
an issue with Edwards EV1000 clinical platform, and are notifying our customers.
Details on affected devices:
The EV1000 clinical platform is used to optimize fluid management through the use of minimally
invasive or non-invasive monitoring technologies.
The EV1000A system consists of the following components to monitor a patient using minimally
invasive technology:
 Monitor
 Databox
 Power adaptor
The EV1000NI system consists of the following components to monitor a patient using non-
invasive technology:
 Monitor
 Pump Unit
 Pressure Controller
 Heart Reference Sensor (HRS)
Description of the problem:

Edwards EV1000A Specifications

General

Brand	Edwards
Model	EV1000A
Category	Medical Equipment
Language	English