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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.
Correct Orientation
Flag Label
Page 1 of 5
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Summary of Contents for Edwards EV1000A
- Page 1 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’...
- Page 2 Power Supply with Cover OR Edwards personnel will visit your facility to apply the Flag Label and Cover. Please note that due to the fluid situation of COVID-19, Edwards Personnel will visit your facility at a later date. Page 2 of 5...
- Page 3 This liquid ingress into the AC inlet can result in smoke, sparks, or fire if fluid bags are allowed to drip on this power inlet. Edwards is releasing a power cord entry cover for the pump unit in the EV1000 NI system to reduce the potential for liquid or other conductive contaminants to enter the AC inlet. Edwards...
- Page 4 If you have any questions, please contact Edwards Tech Support at <phone>. Sincerely, Linnette Torres Vice President of Quality, Critical Care This Update to the Urgent Field Safety Notice has been communicated by Edwards Lifesciences to the relevant competent authority. Page 4 of 5...
- Page 5 For EV1000NI or EV1000CS configuration, fill out with the pump unit serial number and enter an “X” or “Yes” on “Boot & Bracket”, or indicate N/A if you have no product. E-mail the completed form to Edwards Tech Support at <email>, within 5 days from receipt • of this notification Edwards will visit your facilities to implement the corrective and preventive actions •...
- Page 6 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: ...
- Page 7 (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,...
- Page 8 Reference Warnings and Caution Section from Operators Manual Figure from EV1000A Operators Manual on Power Adapter Orientation (Figures 15-8 and 15-9) 3 of 6...
- Page 9 We’ve received reports where liquid is dripping on to the unit which may lead to an electrical short circuit leading to a possible fire hazard due to liquid ingress. Unlike the EV1000A, the EV1000NI AC cord inserts horizontally into the unit. Therefore, orientation is not a factor of liquid ingress.
- Page 10 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>...
- Page 11 Quantity Serial Number of Model Ship To Date Shipped Number Units on hand From EW Name (Print): Title/Dept. Telephone Number: Signature: Date: Please return this form via fax to Edwards Customer Service or Tech Support at: <phone> 6 of 6...
- Page 12 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.
- Page 13 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.
- Page 14 Email the completed form to Edwards Tech Support at tech_support@edwards.com, • within 10 days from receipt of this notification Name (Print): Title/Dept.: Firm Name: Telephone Number: Signature: Date: Please return this form via email to Edwards Tech Support at tech_support@edwards.com Support at: <phone> 3 of 3...
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