Events

Alerta De Seguridad para Pulmonary Ventilator Esprit V-100. Anvisa Registration No. 80102510035. Units at Risk: All Esprit V1000 manufactured before December 31, 2004 and Esprit V1000 manufactured prior to Dec 31, 2004 and converted to Esprit V200.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.; Respironics Califórnia, Inc (Philips Respironics)..

¿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
    1471
  • Fecha
    2014-12-01
  • 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
    The product manufacturer (Philips) has found that the fan hardware mounting screw of the Esprit V1000 and Esprit V200 fans may have been improperly installed, which may cause the end of the screw to touch the printed circuit board (PCBA) and cause a short circuit. This may prevent the ventilator from receiving battery power if the AC power (outlet) is interrupted. There is an auditory alarm on the equipment programmed to be triggered in a situation like this, alerting the medical staff about the loss of energy. Loss of energy in this situation may cause loss of the auxiliary ventilator, which could lead to hypercarbia or hypoxemia.
  • Causa
    Incorrect mounting of the power supply fan screws can cause them to touch the pcba, causing a short circuit and consequently preventing the switch to the battery (dc) when necessary.
  • Acción
    Field correction. The use of the equipment may be continued, but the user should pay attention to the following: (a) be alert for the occurrence of the emergency alarm, which should sound loud and alert that the equipment can not operate via battery; (b) ensuring that alternative forms of ventilation (resuscitator or similar apparatus) are available when the ventilator is in use in a patient; and (c) patients on life-support equipment should be visually monitored by the competent medical staff, as life-threatening conditions that do not trigger the alarm may occur. Follow the instructions in the Operator's Manual and always check life support equipment before using them.

Device

Pulmonary Ventilator Esprit V-100. Anvisa Registration No. 80102510035. Units at Risk: All Esprit...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.; Respironics Califórnia, Inc (Ph...
  • Source
    ANVSANVISA