Edwards EV1000A User Manual

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URGENT FIELD SAFETY NOTICE
ADDENDUM
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:
This letter is in follow-up to our initial communication regarding EV1000 monitors and the risk
associated with smoke, sparks or fire related to the power supply.
In our initial communication, we noted that improper mounting of the power supply could result in
liquid ingress into the adaptor causing a short with the potential to lead to a possible fire hazard.
This letter is to inform you of additional potential causes, our plans to address the issues, and
steps you can take to help minimize risk.
Reports of Burnt Cables:
• We have reports of cables that appear burnt, without smoke, sparks or fire. We continue to
investigate to identify all potential causes. One potential cause is the presence of conductive
material in the AC inlet of the power supply.
• Please assure that there is no conductive material in or near the AC inlet when connecting the
AC power cord to the EV1000 power supply, and that both the AC power cord and inlet are
clean and dry.
Reports of Smoke, Sparks or Fire due to Cleaning or Decontamination/Disinfection:
• The product instructions indicate that product should be kept dry and the cables should not be
immersed in any liquid solution or liquids allowed to penetrate connectors.

Edwards EV1000A Specifications

General

Brand	Edwards
Model	EV1000A
Category	Medical Equipment
Language	English