Events

Alerta De Seguridad para Pulmonary Ventilator Ventilator Circuit. Temperature Transducer (Heated-Wire) In the Ventilator Ventilator Circuit. Coded Products: (1) 780-19, 780-20,780-31 to 780-36,780-51, 780-52, 790-52; (2) 780-23 to 780-25, 780-30; (1 and 2) Lots # 42012 and below; products manufactured before October 15, 2001; units distributed within the US and internationally

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

¿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
    272
  • Fecha
    2002-01-25
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above mentioned fan circuit may have a manufacturing defect (series / batch). in some cases, the cable connector used to secure / hold the guidewire close to the patient, on the y connection, may not have been mounted correctly. this may result in a malfunction in the wire / cable heater. the manufacturer commenced a voluntary correction work through the urgent correction process with a letter dated october 12, 2001.
  • Acción
    Make sure you have received the letter and the white posting card for Hudson RCI return. Identify, isolate, and immediately discontinue use of the affected product in your inventory. The manufacturer recommends follow-up to reduce the possibility of sparking, overheating and / or ignition with the circuit. The following measures are recommended: (1) The wire / cable circuit should never be stretched or with high condensation / secretion. (2) Do not use the breathing circuit for more than 5 days. Complete all required information on the prepaid white return card if you have or have any affected product in your inventory, and return the prepaid return card to Hudson RCI by mail to the address or fax at 1 (909) 676 -1578. For more information on how to return the affected product, obtain the authorization number, or more information, contact your local Hudson RCI representative or directly at 1 (909) 676-5611 in the USA.

Device

Pulmonary Ventilator Ventilator Circuit. Temperature Transducer (Heated-Wire) In the Ventilator V...

Manufacturer

Hudson RCI
  • Source
    ANVSANVISA