Events

Safety Alert for ** Trade Name: VENTILATION SYSTEM 840 ** - Registration: 10139810058 ** - Expiry Date: 05/15/2015 ** - Hazard Class: III - HIGH RISK ** - Model 4-070205-85 ** - Attached Series of products under risk in Brazil

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1338
  • Date
    2013-12-05
  • 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
    If one of your Puritan Bennett ™ 840 ventilators displays the problem code (XB0069), it can no longer be used until serviced, which includes turning the device off and on, and rotate EST. In addition, when using the ventilator on a patient, always follow the instructions as described in the Puritan Bennett ™ 840 Operator's Manual: a) Patients on life support equipment should be adequately monitored by appropriate medical staff and appropriate monitoring devices ( Preface); * b) An alternate source of ventilation should always be available when using a critical care ventilator (Preface); * c) When using the fan volume selectable volume range, be sure to select an alarm volume level that can be differentiated from the background noise levels (Section 5.5).
  • Reason
    Due to a product software error, mechanical ventilation may be interrupted.
  • Action
    The company is conducting a corrective action security field upgrade software. * Attached is the document in the form of "Questions and Answers" made available by the company - Customer Verification Form - Notice to the services

Device

** Trade Name: VENTILATION SYSTEM 840 ** - Registration: 10139810058 ** - Expiry Date: 05/15/2015...

Manufacturer

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