Events

Safety Alert for Trade name: Flow-i Anesthesia System; Technical Name: anesthesia machine. ANVISA registration number: 80259110091; Risk class: III; Affected model (s): C20, C30 and C40; and Batch (s) / Serial number (s) affected: Attached document

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA; MAQUET CRITICAL CARE 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
  • Event ID
    1949
  • Date
    2016-06-07
  • 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
    The technical alarm generated is a warning device that prompts the user to take measures such as reducing the flow of fresh gas (to keep the anesthetic in the breathing circuit) and / or injecting intravenous medications necessary to ensure sufficient depth of anesthesia. ## UPDATED ON 04/09/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Reason
    The technical alarm generated is a warning that the user is advised to take measures such as reducing the flow of fresh gas (to maintain the anesthetic in the breathing circuit) and / or injecting intravenous medications necessary to ensure sufficient depth of anesthesia.
  • Action
    Field Action No. MCC / 16/001 / NU triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA. Anesthesia System Software Update.

Device

Trade name: Flow-i Anesthesia System; Technical Name: anesthesia machine. ANVISA registration num...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA; MAQUET CRITICAL CARE AB
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA