Reusable Oxygen Regulator Gasket Ring 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    373
  • 날짜
    2002-01-31
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    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.
  • 조치
    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

Device

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA