Events

Safety Alert for HEATED UMIDIFIER SERIES M - Models 1051158, 1051157, 1049124, 1049110, 1049109, U1049110, U1049109, R1049110, R1049109 - Registered at Anvisa under number 80102510248 - LOTS / SERIAL NUMBERS - See attached list.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora de Produtos Médicos 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
    987
  • Date
    2009-10-05
  • 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
    This action does not require changing the humidifiers that are operating normally. In addition, CPAP devices used with the humidifier are not affected by this action and end users with affected humidifiers can continue to operate their CPAP therapy devices without the humidifier. Note that only humidifiers with DC power are affected by this action. Humidifiers with AC food are not affected. We have included a figure in the Letter to Users to assist end users / patients in identifying DC powered humidifiers. (Source: VR Medical) Anvisa is following this action.
  • Reason
    Philips respironics is announcing a voluntary recall that affects its line of m series heated humidifiers. some humidifiers may fail to operate due to a potential malfunction of an internal connection between the heating plate and the printed circuit board, which results in a "blinking blue light" on the humidifier control knob.
  • Action
    The actions recommended to users are: (1) Distributors received the list of affected products and were directed to contact the end consumer reporting the problem. (2) To end users, if the alert lead is blinking, Respironics' orientation was to disconnect the power supply from the Humidifier and follow the instructions in the troubleshooting guide on page 18 of its User Manual. If this condition continues, the appliance will be replaced free of charge.

Device

HEATED UMIDIFIER SERIES M - Models 1051158, 1051157, 1049124, 1049110, 1049109, U1049110, U104910...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos Ltda
  • Source
    ANVSANVISA