Events

Alerta De Seguridad para PURITTAN BENNET 840 FAN, Anvisa Registration No. 10139810058, Class of Risk: III (High Risk).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TYCO HEALTHCARE INC.; NELLCOR PURITAN BENNETT.

¿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
    860
  • Fecha
    2007-04-12
  • 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
    Under normal fan conditions, the safety valve opens in case of occlusion of the ventilation circuit and closes when this circuit is released. Occasionally, however, this valve may remain open, despite the release of the ventilation circuit. If the valve does not close again, the ventilator detects a disconnection of the circuit and triggers an audible alarm. The fan then stops working normally and even if the valve remains in the open position, the visual alarm indicating the valve opening does not appear and the message "circuit switched off" appears on the screen. In the event of equipment failure, Tyco Healthcare recommends the following: (1) Disconnect the patient from the 840 ventilator and, if necessary, ventilate the patient alternatively; (2) Turn off fan 840; (3) Turn on fan 840; (4) Select the "same patient" option and ensure that the fan parameters are set correctly. (5) Reconnect the patient to the ventilator 840. Anvisa is following this case in Brazil.
  • Causa
    Possible failure of the puritan bennet 840 fan diode. the problem concerns only fans (model 840) and replacement components manufactured and marketed between 1 june 2006 and 8 february 2007.
  • Acción
    Tyco Healthcare (manufacturer) reports that it has already instituted an informational and corrective action with the parties involved. According to information provided to Anvisa, Mallinckrodt Ltda (distributor in Brazil) has already sent letters of explanation to its customers and is expected to complete the recall for 06/30/2007. For more information, please access the following electronic addresses: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2007/860.pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2007/ 860_1.pdf #### Update (03/10/2007): Mallinckrodt Ltda informed Anvisa that it has already updated 90 fans in Brazil, out of a total of 173 fans at risk in the country. The company is awaiting the arrival of material already sent by the equipment manufacturer to finalize the recall. #### Update (01/22/2008): Mallinckrodt Ltda informed Anvisa that the recall of the Puritan Bennet 840 Ventilator is in progress. According to the information presented by the company, 135 equipments (out of a total of 173) have already been updated. Mallinckrodt Ltda already has the circuit boards for the correction of the remaining 38 equipment and intends to finalize the recall until the end of January 2008. #### Update (14/08/2008): Mallinckrodt Ltda informed the UTVIG on completion of the collection of the Purittan Bennet 840 ventilator. Circuit boards of 173 units have been replaced, which should be re-exported to the USA.

Device

PURITTAN BENNET 840 FAN, Anvisa Registration No. 10139810058, Class of Risk: III (High Risk).

Manufacturer

TYCO HEALTHCARE INC.; NELLCOR PURITAN BENNETT
  • Source
    ANVSANVISA