Events

Alerte De Sécurité sur ALL GAZE CYLINDERS

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 N/A.

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
    5
  • Date
    2001-05-14
  • 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
    Ecri received reports indicating that while the cylinders with gases compressed identifying their contents, the staff of the hospital can inadequately trust in secondary indicators like the color of the cylinders or the pins of the connect.
  • Action
    MAKE SURE ALL YOUR RELATED STAFF ARE ADEQUATELY TRAINED AND DISTRIBUTE THIS ALERT FOR EVERYONE. PERIODIC UPDATE COURSES OR NEW EMPLOYEES ARE IMPORTANT TO PREVENT RISK. (1) WHEN CHOOSING A CYLINDER FOR USE SHOULD READ THE LABEL TO BE SURE THAT IS THE CORRECT GAZ. CAUTION TO SEE THE COLOR IS ADDITIONAL. CHECK THAT THE CYLINDER GAZ OUTPUT AND THE GAZ ENTRY INTO THE SITEMA TO BE ADJUSTED PERFECTLY. DO NOT ASSUME THAT THE COVER OR CONNECTION CAN CORRECTLY IDENTIFY THE GAZ CONTAINED IN THE CYLINDER. IF THE LABEL IS MISSING OR IS NOT LEVELABLE, DO NOT USE THE CYLINDER. IF THE CONNECTORS ARE COMPATIBLE, DO NOT MODIFY THE CONNECTORS OR USE THE CYLINDER, SEE WHAT IS WRONG. (2) IN THE NEXT EQUIPMENT INSPECTION, ENSURE THAT ALL THOSE WHO USE CYLINDERS HAVE THEIR PINS AND CONNECTORS FOR THE SPECIFIC GAZ CYLINDERS REQUIRED. (3) DO NOT REMOVE OR MODIFY GAZ CONNECTORS WITHOUT CONSULTING THE EQUIPMENT MANUFACTURER. (4) DO NOT BUY MEDICAL GAS CYLINDERS WITH CRADLE DIAGRAMS OR NON-STANDARD CONNECTORS.

Device

ALL GAZE CYLINDERS
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA