Events

Safety Alert for Emergency Ventilator and Transportation, Oxylog 3000 Plus models; Oxylog 2000 Plus; Oxylog 3000, registration 10407370097; 10407370073, hazard class III, several lots / series (SEE ANNEX).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Drager Indústria e Comércio Ltda.; Dragerwerk AG & Co. KGaA..

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
    1810
  • Date
    2016-02-01
  • 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
    Strengthen the instruction that in case of technical failure "Poti unplugged turn off the equipment, adjust the relevant control at least ten times to the minimum and maximum values. Turn the power on again.
  • Reason
    During the operation of the equipment, some "poti unplugged" error message with acoustic and visual alarm, the system is depressurised and the ventilation function is interrupted.
  • Action
    Supplement to Instruction for Use. Action Code PR58431_TSB 201. As a preventive measure the company Drager Indústria e Comércio Ltda. Advises users that all rotary control knobs must be handled with the appliance switched off at least 10 times to the left side and the right side (reaching the minimum and maximum values ​​of each).

Device

Emergency Ventilator and Transportation, Oxylog 3000 Plus models; Oxylog 2000 Plus; Oxylog 3000, ...

Manufacturer

Drager Indústria e Comércio Ltda.; Dragerwerk AG & Co. KGaA.