Alerta De Seguridad para Ambu Resuscitation, Self-Inflating, Manual

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
  • Causa
    The medical devices agency (mda / uk) issued a safety alert upon receipt of an incorrect reassembly report from the manual resuscitator, which rendered them ineffective in emergency situations. mda states that various components of these appliances have been incorrectly positioned, and valves have been reversed.
  • Acción
    MDA recommends the following care: (1) The Manual Resuscitator should only be cleaned and reassembled by appropriately trained personnel following the manufacturer's instructions. (2) During cleaning, the resuscitator must be thoroughly checked (checked) for correct operation. (3) The Manual resuscitator should only be used by individuals who have received adequate training. MDA states that Medical Devices Controls Assurance Standards practice guidelines should be followed and these current / current standards are available on the Internet at For more information, contact the ANVISA Technovigilance Unit, by e-mail or by telephone (61) 448-1485. Comments: ECRI also wrote about this problem (testing reuse of manual resuscitators). Health Devices August 28, 1999 [8]: 323). Also, note that MDA says that Manual Resuscitators that are inadequate will not work, but also, according to ECRI's warning, can cause harm to patients when resuscitators are handled or reassembled improperly. As a result, ECRI suggests that these products be checked for proper operation prior to each use. Comments: This incident is based on information from the MDA vendor that may not be independently verified with respect to the accuracy or causal relationship with specific products or vendors.


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