Events

Safety Alert for Intensive Care Respirators

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    232
  • Date
    2000-12-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Ecri member hospitals have reported that clinicians are not responding quickly to critical alarms that are more musical in the latest intensive care respirator model. they report that the reason for all this is the non-recognition of alarms in more musical tones as alarms of urgency by the clinicians themselves. ecri reports that a delayed response may compromise the patient's condition or result in death.
  • Action
    ECRI recommends (1) Please advise the staff in charge of this ECRI report and the alarm recognition problem. (2) Establish and initiate a program of awareness and recognition of alarms on respirators. (3) Ensure that all respirator patient care personnel are familiar with the importance and urgency of alarms with a more musical sounding of these respirators. For more information, contact your local representative or directly with ANVISA's Technovigilance at 0xx61-448-1331.

Device

Intensive Care Respirators
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA