Events

Safety Alert for (1) LTV 900, (2) LTV 950, (3) LTV 1000, SERIAL NO. (1) LESS THAN B01541, (2) LESS THAN C01275 , (3) MINOR THAN A02066.

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

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
    54
  • Date
    2001-05-14
  • 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
    The alarm failure risk is alert on the fans. in the cpap mode, if the patient accidentally disconnects and if the volume minute is set with parameter <0.7l / min, the alarm of these fans may not sound. beyond this, as these fans perceive self-recycled breathing as patient effort, the apnea alarm does not soar. the manufacturer began this correction in letter of april 4, 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE PULMONETIC CORRECTION NOTIFICATION LETTER OF APRIL 4, 2000. IDENTIFY, ISOLE ALL THESE PRODUCTS THAT MAY BE AFFECTED. FOR FURTHER INFORMATION CONTACT YOUR PULMONETIC SYSTEMS REPRESENTATIVE OR CONTACT JOE CIPOLLONE ON THE PHONE (0021-1-909-783-2280).

Device

(1) LTV 900, (2) LTV 950, (3) LTV 1000, SERIAL NO. (1) LESS THAN B01541, (2) LESS THAN C01275 , (...

Manufacturer

PULMONETIC SYSTEMS INC
  • Source
    ANVSANVISA