Alerta De Seguridad para Anesthesia System Anesthesia System ANVISA Registration Number: 80259110040 Hazard Class: III - High Risk Affected Model: FLOW-i C20, FLOW-i C30, FLOW-i C40 Affected serial numbers : 2781; 4261; 4262; 4263

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA.; Maquet Critical Care AB.

¿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
    2055
  • Fecha
    2016-06-07
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Field action consists of replacing all affected PC Cards in the installed base. This Field Security Notification is only applicable until the FLOW-i system has been updated with the replacement of the PC Cards. WARNING: If the malfunction occurs during operation, activate the built-in emergency ventilation and switch to an alternative anesthesia system or anesthesia method. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link #### UPDATED ON 09/4/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Causa
    The flow-i system can not be started or if in use, it stops ventilation. maquet discovered a potential problem caused by welding problems, causing a short circuit, on two different pc-boards in flow-i. this could cause restarts followed by deactivation of one of the subsystems. on 11/23/2015, maquet initiated a field action on this subject covering a batch of affected pc-boards. maquet has already been informed by the supplier of pcboards that more batches are affected and therefore the field action has been expanded. depending on which pc card is affected the symptoms are different: pc card 1920 control in standby mode: the case can not be started. te10 displayed. during operation: ventilation stops. te10 displayed. the alarm sounds. pc card 1921 monitoring in standby mode: no parameter or indicator on the standby screen. can not start the case. the alarm sounds after 10s. during operation: ventilation continues, but the parameters and indicators are not on the screen. vaporizers are turned off (no power). the alarm sounds after 10s.
  • Acción
    Field Action Code MCC 15 007 IU / EVU-156075 triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA, which consists of field correction to replace all affected PC cards in the installed base.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA