Events

Safety Alert for PURITTAN BENNET 840 FAN, Anvisa Registration No. 10139810058, Class of Risk: III (High Risk). ## Puritan Bennett 840 fans subject to this Field Action correspond to the manufacturing interval from March 2010 to September 2010 ## SEE Distribution Map (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.; 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
    1395
  • 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 company that owns the product registration - AUTO SUTURE DO BRASIL LTDA - recommends: If the loss of the graphical user interface (GUI) is identified, the following measures must be taken in conjunction with the institutional protocols: - Check respiratory stability and psychological aspects of the patient; - Confirm that the patient is receiving respiratory support by observing the expansion and contraction of the patient's chest; - Evaluate the current situation of the patient by analyzing other monitoring (eg, oxygen saturation, heart beat, blood pressure, etc.); - Immediately transfer the patient to an alternative ventilator in a manner consistent with the institutional protocol; - Remove the affected fan from use until it is repaired.
  • Reason
    The field action was triggered by customer reports that reportedly lost information on the graphical user interface (gui) display while the ventilator continues to provide respiratory support. client reports describe that gui display screens (upper and lower) erase during patient use. this event interferes with the physician's ability to see and / or change the fan settings or the alarm parameters set by him. note that in all cases reported so far, the ventilator continues to provide respiratory support during these events. the loss of graphical user interface (gui) display due to power supply failure (psu) is demonstrated by the fan when entering the "gui inop" state, as described below: the puritan bennett 840 fan is designed with one unit (bdu) that works independently of the graphical user interface (gui). both systems actively monitor and communicate with each other as part of normal operations. if the breathing supply unit (bdu) loses communication with the graphical user interface (gui), it recognizes this and enters a "gui inop" mode. it initiates the appropriate alarm consisting of a visible alarm indicated by the red light of the "gui inop" on the breathing supply unit (bdu) and a high priority audible alarm. it should be noted that the fan will continue to operate normally.
  • Action
    Company holding the registration in Brazil - AUTO SUTURE DO BRASIL LTDA - will make correction in the field and, if necessary, replacement of the Power Supply. ## SEE: 1. Letter to Clients (Annex 2); 2. Traceability Form (Annex 3); 3. Questions and Answers (Annex 4).

Device

PURITTAN BENNET 840 FAN, Anvisa Registration No. 10139810058, Class of Risk: III (High Risk). ## ...

Manufacturer

AUTO SUTURE DO BRASIL LTDA.; 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