Events

Safety Alert for Trade Name: VENTILATION SYSTEM 840 # Registration: 10349000386 -. Risk Class: III - HIGH RISK # MODELS 4-072214-00; G-062010-00. The series under risk in Brazil and the respective client are in Annex 1.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.; NELLCOR PURITAN BENNETT IRELAND.

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
    1355
  • Date
    2014-02-14
  • 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
    Complaints have been received from clients in which they declare that the O2 sensor inside the ventilator is not working and that they need to move a patient from one ventilator to another surrogate mechanical ventilation. • If a sensor becomes nonfunctional during use and can not be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied oxygen level of the ventilator and provide the appropriate alarms. o A non-functional O2 sensor does not affect the oxygen concentration supplied by the fan and does not control the flow of gases. • If a sensor becomes non-functional and the institution's protocol requires the transfer of a patient to a surrogate ventilator, the patient should be clinically evaluated to determine the best transfer conditions to reduce patient risk. - According to information of the company the Field Action was completed.
  • Reason
    Conflicting information was provided to puritan bennett 840 fan customers in an addendum to the label (p / n 066009a 09/02) stating that the oxygen sensor should be replaced every two years. the correct operational life is one year from the manufacturing date, as stated in the puritan bennett 840 fan operator's manual. the sensor, p / n 4-072214-00, must not be used after the expiration date printed on the oxygen sensor packaging. puritan bennett 700 series fan operator and service manuals also state that the oxygen sensor should be replaced every two years. the sensor, p / n g-062010-00, should not be used after the expiration date printed on the oxygen sensor package.
  • Action
    Company is submitting to its customers document with label update (Annex 2)

Device

Trade Name: VENTILATION SYSTEM 840 # Registration: 10349000386 -. Risk Class: III - HIGH RISK # M...

Manufacturer

AUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.; NELLCOR PURITAN BENNETT IRELAND
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA