Events

Safety Alert for ANESTHESIA MACHINES EXCEL 80 SERIAL NUMBERS: AMKB00100 TO AMKB00152, AMKC00100 TO AMKC00191, AMKD00100 TO AMDKD00149, AMLB00100 TO AMLB00540, AMLC00100 TO AMLC00308, AMLC00327 TO AMLC00356, AMLD00100 TO AMLD00446, AMLD00448, AMLD00461 TO AMLD00503, AMLD00536 TO AMLD00551, AMLD00572 TO AMLD00587 .

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Distributed by Datex-Ohmeda.

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
    36
  • Date
    2001-04-14
  • 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
    This machine can release higher quantities of anesthetic agents than that indicated on the vaporizer bookmark, due to incorrect mounting of internal gas tubes, inside the machine. datex-ohmeda affirms that other anesthesia machines, or.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE DATEX-OHMEDA LETTER OF FEBRUARY 19, 2001. IDENTIFY ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. REPORT USERS IN YOUR ESTABLISHMENT OF THE PROBLEM WITH THESE MACHINES. DO NOT USE THESE MACHINES WITH INHALATION ANESTHETICS UNTIL THEY ARE INSPECTED, AND IF NECESSARY, RE-WORKED AND RE-TESTED BY DATEX-OHMEDA'S AUTHORIZED TECHNICAL REPRESENTATIVE. DATEX-OHMEDA AFFIRMS THAT THESE MACHINES CAN BE USED WITHOUT PROBLEMS IF THEY ARE ONLY USED WITHOUT ANESTHETIC INHALATION AGENTS. CONTACT THE AUTHORIZED SERVICE TO MARK A FREE INSPECTION ON THE AFFECTED MACHINES, SO THAT THE PROBLEM IN THESE IS CORRECT.

Device

ANESTHESIA MACHINES EXCEL 80 SERIAL NUMBERS: AMKB00100 TO AMKB00152, AMKC00100 TO AMKC00191, AMKD...

Manufacturer

Distributed by Datex-Ohmeda
  • Source
    ANVSANVISA