Events

Safety Alert for EV1000 Databox and Monitor

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Edwards Lifesciences.

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
  • Date
    2016-05-30
  • Event Date Posted
    2016-05-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160530.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: edwards lifesciences ev1000 databox and monitor medical device manufacturer, edwards lifesciences, has issued a medical device safety alert concerning its ev1000 databox and monitor [model number: ev1000a]. the safety alert reinforces the proper set up of the external power supply according to the equipment operator manual. the manufacturer has recently been notified about an electrical fire that initiated at the power supply of one of the ev1000a system due to noncompliant system installation configuration which caused fluid ingress to the power supply. the manufacturer is not removing product from commercial distribution. the manufacturer is informing all affected users with ev1000a systems to confirm compliance of installation configuration against the current requirements documented in the operator’s manual section ev1000 power adapter mounting bracket. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 may 2016.

Device

EV1000 Databox and Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Edwards Lifesciences EV1000 Databox and Monitor
  • Manufacturer
    Edwards Lifesciences

Manufacturer

Edwards Lifesciences