Events

Safety Alert for Product name: EV1000A - INTENSIVE CARE MONITOR (Vital Signs Monitor) / model EV1000A / registration 80219050127 / risk class III - High Risk // Series affected: document attached.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA; EDWARDS LIFESCIENCES LLC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1911
  • Date
    2016-06-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Action Recommendation to be Taken by the User: All EV1000A systems installed are within the scope of this action. This is a way to remind you that the EV1000A Manual alerts you to immersion of the device or its components into fluids and warns you to prevent fluids from entering the devices (the reference is included in the "Safety and Precautions" section of the Operator), and that the external power cable for the EV1000A must be installed as shown in the manual (Figures 15-8 of the EV1000 Power Adapter Mounting Bracket section and Figures 15-9 of Power Cable Bracket Adapter, included in the Manual), where the AC cable connects to the source, as suggested in the illustrations. Please take this opportunity to review how your EV1000A is installed and the system settings at the installation site to make sure it is configured and installed as per the operator's manual specifications in order to minimize any possible risk of fluid in the source or cables.
  • Reason
    Edwards lifesciences has initiated a safety alert regarding the ev1000a system to enhance the proper use and execution of the external power cable configuration in accordance with the equipment operator's manual. the company has recently been notified of an electric fire event and therefore this notification will be sent to all customers whose ev1000a system is installed to confirm the installation according to the requirements documented in the operator's manual, ev1000 system accessories section. ev1000 power adapter assembly (cap.15). the consequence of using the power cord incorrectly is fire, sparks, or smoke.
  • Action
    Action code FCA77. Send letter to customers to reinforce the proper use and execution of the external power cable configuration according to the equipment operator's manual.

Device

Product name: EV1000A - INTENSIVE CARE MONITOR (Vital Signs Monitor) / model EV1000A / registrati...

Manufacturer

EDWARDS LIFESCIENCES COMÉRCIO DE PRODUTOS MÉDICO-CIRÚRGICOS LTDA; EDWARDS LIFESCIENCES LLC