Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; DATEX-OHMEDA INC..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1834
  • Fecha
    2016-02-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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 "
  • Causa
    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). ".
  • Acción
    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.