Events

Safety Alert for VENTILATION SYSTEM 840 # Technical Name: Ventilator Pressure and Volume # Registration: 10139810058 # Hazard Class: III - HIGH RISK # Product Code: 4-075907-00 # AFFECTED SERIES: Serial numbers including sequence from 3510012377 to 4200000001 #

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

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
    1408
  • Date
    2014-06-25
  • 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 Health Services that have the affected equipment must ensure that the measures proposed by the Field Action are executed in their equipment. The company reported that its customers were notified on 06/24/2014. Map of Distribution / List of clients in annex.
  • Reason
    According to the manufacturer (covidien), it "is issuing this voluntary field security corrective action (fsca) for certain puritan bennett ™ 840 fans that contain a certain back light inverter (pcba) printed circuit board. of the affected backlight (pcba) is only present on the puritan bennett 840 ventilators with a 9.4-inch graphical user interface (gui) set.This voluntary field safety corrective action is being taken in response to customer reports on the loss of information on the graphical user interface (gui) display while the ventilator continues to provide respiratory support.Customer reports describe that gui display screens (upper and lower) erase during patient use.This event interferes on the doctor's ability to see and / or change the fan settings or the alarm parameters set by him. during these events. ".
  • Action
    Company will make Correction in the field - Software update - Circuit replacement - Preventive maintenance # Company informed that its clients have been sent the following guidelines regarding the Field Action: 1. Letter of Communication to Clients (Attached); 2. Verification Form (Attached); Questions and Answers (Attached).

Device

VENTILATION SYSTEM 840 # Technical Name: Ventilator Pressure and Volume # Registration: 101398100...

Manufacturer

COVIDIEN LLC.; MALLINCKRODT DO BRASIL LTDA
  • 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