Safety Alert for Reusable Oxygen Regulator Gasket Ring

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
  • Date
  • Event Country
  • Event Source
  • 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
  • Reason
    Ecri has investigated some cases of damage, fire, and injury involving reuse of the o-ring gasket (also called captured washers) in size e. to the extent that the sealing ring is used, it may wear out, requiring a stronger tightening / locking to effectively seal the regulator to the cylinder valve or check valve. users typically use tools to tighten (tighten) the screw that locks (seals) the regulator, which can damage both the ring and the regulator. fire sparks from the area of ​​the sealing ring occurred in the case where the sealing ring began to dislodge or damage during use or was used in conjunction with a second ring; some of these fires caused injuries.
  • Action
    ECRI recommends the following steps to prevent fires, projectiles, or damage to regulators leaks: (1) Alerting the appropriate team of this problem. (2) Only use fluorocarbon elastomer (eg Fluorel, Viton) or bronze ring because these components are more difficult to ignite / ignite in an atmosphere with a lot () with O2. Other types of reusable caulks are not as resistant to ignition. Your regular supplier must be able to provide such caulking. (3) Inspect the reusable gasket at each cylinder change. Do not use sealing rings that are deformed, disfigured, flattened, torn or leaking. Use a new sealing ring if the good seal between the regulator and the cylinder valve can not be easily tightened (hand-tightening). (4) Do not attempt to stop a leak by using tools on the regulator, as this may cause significant damage to the screw or regulator (regulator yoke). Check valve regulator should only be turned on by manually adjusting (hand-tightening) the clamping handle. (5) Do not attempt to repair the leak while the apparatus is under pressure. Allow (let) pressure to dissipate first. (6) Remove from service any regulator who is obviously abused or with any other damage


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