Events

Safety Alert for The products affected by this field action are registered in ANVISA as: (i). Aisys Anesthesia System (Registration 80071260326) - Aisys CS2 Model; (ii). Aisys Anesthesia Machine (Registration 80071260272) - Aisys Model. Thus, all Aisys CS2 anesthesia devices (GTIN: 840682102292) and upgraded AISYS anesthesia devices (ie Aisys touch screen devices and 10.X software version) are affected. Software versions other than 10.X are not affected. DISTRIBUTION MAP IN ANNEX.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; DATEX-OHMEDA 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
    1834
  • Date
    2016-02-26
  • 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
    According to the company, the client "(...) can continue to use his anesthesia machine. If its practice involves the use of 21% O 2 in the fresh gas, any adjustment of the fresh gas flow rate will produce an inhaled bolus of anesthetic agent. The effect of the bolus on the concentrations of inhaled and expired agents is short-lived. Note the possible effects of elevated anesthetic agent concentration for short periods of time. In the event of the problem described above, the anesthesia device will automatically recover and return to the configured concentration of constant state anesthetic agent without any action of the user. Depending on the system configuration, one or both of these alarms can be activated if this safety problem occurs: • Clinical alarm "Fi XXX High" (XXX indicates the specific agent) • Alarm if respiratory gas monitoring is not present "
  • Reason
    According to the company, "as of december 7, 2015, ge learned of a potential safety problem involving momentary autocorrection of the anesthetic agent bolus when using oxygen at 21% on all updated aisys cs2 and aisys appliances (version 10.X). aisys cs2 and aisys upgraded anesthesia machines can produce a momentary autocorrection of the increase in anesthetic agent, affecting inspiratory and expired concentrations for a short period of time, after one of the following configuration changes: • altering the fresh gas oxygen at 95% -25% for air only (oxygen at 21%). • any change in the total flow while using oxygen at 21% (air only). the occurrence of failure may generate momentary bolus production of anesthetic agent. the bolus will not occur with nitrous oxide as the carrier gas (balance) or when the oxygen concentration is set above 21% (air only). ".
  • Action
    The company will perform field correction for software upgrade. LETTER TO THE CUSTOMERS IN ANNEX. IMF Code 34075

Device

The products affected by this field action are registered in ANVISA as: (i). Aisys Anesthesia Sys...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; DATEX-OHMEDA INC.