Events

Alerte De Sécurité sur WASHER AND AUTOMATIC ENDOSCOPE REPAIRER AER - registered in Anvisa under the number 80145900728 - Code 20301 - Serial numbers / Lots: EP1151741; EP1151742; EP1151744; EP1151747; EP1151715; EP1151568; EP1151390; 4024730; 3024357; EP1151459; EP115119; EP115910; EP1151116.

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 JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA A SAÚDE LTDA..

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
    986
  • Date
    2009-09-28
  • 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
    The company informs that the procedures are already described in the Equipment User Manual, but the manufacturer is highlighting these instructions to reinforce that the endoscopes must be processed according to the disinfectant manufacturer's instructions for use. Failure to follow these instructions may result in improperly disinfected endoscopes.
  • Cause
    The company reports that it has detected the need to reinforce the importance of defining the disinfection cycle when using the aer endoscope automatic washer and reprocessor and remind users to observe the light on during the cycle. (source: johnson & johnson).
  • Action
    The actions recommended to users of the product are as follows: (1) Verify receipt of the letter and the company's label; (2) Identify all affected equipment; (3) Attach the label to the front of the product; (4) Complete the form that accompanies the label and return it to the company to confirm that it has received the label to be affixed to the equipment; (5) Verify that the disinfection time is in accordance with the disinfectant manufacturer's instruction manual; (6) If the temperature of 25 ° C is as required by the disinfectant manufacturer's instructions for use, make sure that the TEMPERATURE light is on before beginning the disinfection cycle. (Source: Johnson & Johnson)

Device

WASHER AND AUTOMATIC ENDOSCOPE REPAIRER AER - registered in Anvisa under the number 80145900728 -...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA A SAÚDE LTDA.