Safety Alert for ALL GAZE CYLINDERS

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

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
    5
  • Date
    2001-05-14
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    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

  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA