Events

Safety Alert for FAN WITH HIGH-FREQUENCY OSCILLATORS FOR INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) MODEL 8000 DRAEGER BABYLOG PLUS HFO MODE, (2) MODEL 3100A SENSORMEDICS, (3) MODEL 2000 SLE HFO, (5) CONNECTORS OF ENDOTRACTICAL TUBES OF 3.0 MM OR LESS SIZE, (6) ENDOTRACTICAL TUBES OF 3.0 MM OR LESS SIZE.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DRAEGER LTDA.; EME [ELECTRO MEDICAL EQUIPMENT] LTDA.; SLE LTDA.; FABRICANTES NÃO IDENTIFICADOS NO ARTIGO..

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
    53
  • Date
    2001-06-08
  • 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
    A medical devices agency, mda / uk, alert on the risk of alarm failure in fans with high frequency oscillation. these fans may not detect the pressure changes in accidental extinguish or disconnect cases between 3.0 mm or smaller tubes and connectors, due to low resistance to gas flow.
  • Action
    (1) DRAEGER MODEL 8000 BABYLOG PLUS FANS DETECT EXT. OR DISCONNECT AND ALARM IF FLOW MONITORING IS CONNECTED AND VOLUME-MINUTE ALARM IS PROPERLY PLACED. (2) WITH THE MODEL 3100A SENSOREDICS, IN CASE OF EXTUBLATION OR DISCONNECTION OF MINOR PIPE TUBES, THE PRESSURE ALARM DOES NOT UNLOCK. THE MANUFACTURER SENSOREDICS MODIFIED THE INSTRUCTIONS FOR USE IN A TECHNICAL BULLETIN OF MAY 4, 2001 TO ALERT OPERATORS WHEN VENTILATING PATIENTS WITH 3.0 MM OR SMALLER TUBES IN THE CASES OF EXTINGUISHING OR DISCONNECTING THE TUBES TO THE CONNECTORS, ONLY FLOW MONITORING (SLE MODULE 2100), SPO2, OR PTO2 / PTCO2 WILL CONDITIONALLY WARN THE PROFESSIONALS OF AN ALERT SITUATION, BUT NOT THE PRESSURE MONITORING. WITH THESE SLE FANS, THERE WILL ONLY BE DETECTION AND ALARM IN THESE CASES IF THE ALARM LEVELS ARE ADJUSTED UNDER AGREEMENT. THIS, BUT, MAY REQUIRE VERY REFINED, DIFFICULT ADJUSTMENTS. AT LEAST, THE MANUFACTURER RECOMMENDS ACTIVE SURVEILLANCE AND PATIENT STRATEGY MONITORING. FOR FURTHER INFORMATION, CONTACT THE MANUFACTURERS 'LOCAL REPRESENTATIVES. IN CASE OF NEED, DR D. SIMS DA DRAEGER (PHONE 0021-44-144-221-3542 OR FAX 0021-44-144-221-0327) AND MR M. BURRELL DA SLE (PHONE 0021-44-208-681 -1414 OR FAX 0021-44-208-649-8570), AS WELL AS SR B. MCALEESE (TELEPHONE 0021-44-127-364-5106 OR FAX 0021-44-127-364-5101), WERE INDICATED BY MDA AS PEOPLE-RESOURCES AVAILABLE. ALWAYS CIT THE REFERENCE NO. 24/07 / 20010228.012-4.

Device

FAN WITH HIGH-FREQUENCY OSCILLATORS FOR INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) MODEL 8000 DRAE...

Manufacturer

DRAEGER LTDA.; EME [ELECTRO MEDICAL EQUIPMENT] LTDA.; SLE LTDA.; FABRICANTES NÃO IDENTIFICADOS NO...
  • Source
    ANVSANVISA