Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Hudson RCI.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    272
  • Date
    2002-01-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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...
  • Modèle / numéro de série
  • Manufacturer
    Hudson RCI

Manufacturer

Hudson RCI
  • Source
    ANVSANVISA