Events

Safety Alert for Vivo 50 Home Care Ventilator

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

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
    2015-07-24
  • Event Date Posted
    2015-07-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150724.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: breas vivo 50 home care ventilator the united states food and drug administration (fda) has issued a medical device safety alert concerning breas vivo 50 home care ventilator [all vivo 50 ventilators (215000, 215016) with firmware version 2.04], manufactured by breas medical ab. according to the fda, unintended treatment termination could result from a keypad malfunction in some situations. the device erroneously interprets this as a stop treatment instruction. an alarm will not sound, or be registered. accessories and monitoring equipment connected to the vivo 50 will stop functioning as the device enters stand-by mode. for details, please refer to the fda website:http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-2094-2015&w=07222015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 july 2015.

Device

Vivo 50 Home Care Ventilator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Breas Vivo 50 Home Care Ventilator
  • Manufacturer
    Breas Medical AB

Manufacturer

Breas Medical AB