Events

Alerta De Seguridad para ALL GAZE CYLINDERS

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

¿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
    5
  • Fecha
    2001-05-14
  • 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
    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.
  • Acción
    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
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA