Events

Alerta De Seguridad para Ventilator - E360BR - Anvisa Registration No. 80113010007 - Risk Class III ## Series Affected: E360A1011188 to E360A1211170 / E360TA0113013 to E360TA1213066 (Distribution Map in Annex 1)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por RESPIRATORY CARE HOSPITALAR LTDA..

¿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
    1398
  • Fecha
    2014-06-16
  • 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
    Recommendations of the company that holds the product registration in Brazil: If the alarm is not triggered, the following actions must be taken, together with the institutional protocols to mitigate the risk to the patient: 1. Check the respiratory and physiological stability of the patient; 2. Read the alarm descriptions in the fan GUI and activate the alarm according to the institutional protocol; 3. Remove the affected fan from use until the audible alarm loss event is resolved by updating the fan software or by cycling the power (for example, turning the fan on and off). This should reset audible alarms. If the fan power cycle does not restore audible alarms, the equipment should be out of order.
  • Causa
    According to the description of the notification made by the company, the audible alarm of the equipment may not be triggered when the ventilator is in the alarm state. according to the company, this loss of audible alarm is related to a software error, which means that the configuration of the single board computer (sbc) does not allow audible alarms to operate in an alarm condition. it should be noted that the equipment has a visual alarm that continues to operate properly. in the event of an apnea, the equipment automatically activates the reserve ventilation guaranteeing the minimum volume to the patient. according to the company, there were no reports of this failure in the equipment sold in brazil.
  • Acción
    The company informed that it will do "Field Correction to update the software" (See Annexes 2, 3, 4)

Device

Ventilator - E360BR - Anvisa Registration No. 80113010007 - Risk Class III ## Series Affected: E3...

Manufacturer

RESPIRATORY CARE HOSPITALAR LTDA.