Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Hudson RCI.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    272
  • Date
    2002-01-25
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    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