Safety Alert for FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIRD PRODUCTS CORP SUB THERMO ELECTRON CORP..

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
    83
  • Date
    2001-02-02
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    The alarm failure risk is alert on the fans. these fans may not detect the pressure changes in accidental cases of extinguish or disconnect between the flow tubes for the child and the "sensor" interface. this occurs when the flow sensor to the child remain connected to the circuit. these fans may also fail to impose respirators when used with the sensor in tcpl simv mode, programmed for low assistance sensitivity. the manufacturer began this correction in letter of 28 september 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE IBRD CORRECTION NOTIFICATION LETTER ON SEPTEMBER 28, 2000, REGARDING THE CPUS A, BE MONITOR OF VOLUME; INSTALLATION INSTRUCTIONS AND BIRD PRODUCTS VERIFICATION SHEET. IDENTIFY AND ISOLE THESE PRODUCTS. AGENDE WITH THE IBRD TECHNICAL SERVICE TO COME TO YOUR ESTABLISHMENT TO CHANGE THE CPUSES OF EACH OF THESE FANS. THEN COMPLETE THE CHECK FORM AND RETURN IT TO THE IBRD, ADJUSTMENT DEPARTMENT, BY FAX (0021-1-760-778-7274) OR BY MAIL (TO ADDRESS: 1100 BIRD CENTER DR, PALM SPRINGS CA 92262-8099 USA ). FOR FURTHER INFORMATION CONTACT YOUR IBRD OR PHONE REPRESENTATIVE (0021-1-760-778-7200).

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