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Edwards Lifesciences has identified a potential risk, which may occur during the use of the
EV1000 clinical platform with minimally invasive and non-invasive technologies. Edwards
Lifesciences has received a limited number of reports regarding fluid ingress into the AC power
outlet on both the EV1000A power adaptor and the EV1000NI pump unit.
This is a voluntary safety notice regarding the EV1000 clinical platform to reinforce the proper set
up of the external power supply according to the equipment operator manual. Edwards
Lifesciences has been notified about the potential for an electrical short circuit leading to a
possible fire hazard due to liquid ingress. This issue was noticed at the AC cord of an EV1000
clinical platform due to incorrect orientation. Edwards Lifesciences is not removing product
from commercial distribution.
Based on review of previous instances, we strongly advise you to be cautious that IV bags and
other fluids need to be positioned away from AC power connectors in order to avoid liquid
ingress.
For EV1000A clinical platform installations:
We are informing all customers with EV1000A clinical platforms to confirm compliance of
installation configuration with the current requirements documented in the Operator’s Manual
section EV1000 Power Adapter Mounting Bracket.
This notification is a reminder that the EV1000A Operator’s Manual warns about immersion of
the device or its components and warns against letting fluid enter the device (reference is
included in the Warning and Caution section of the Operator’s Manual).
The external power supply for the EV1000A should be installed as illustrated in the Operator’s
Manual (Figure 15-8 EV1000 Power Adapter Bracket and Figure 15-9 EV1000 Power Adapter
Bracket included in the Operator’s Manual) where the AC cord plugs into the power supply,
exactly as shown in the illustrations in the Operators Manual.
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