Hospital Gas Cylinders with Gas Cylinder Valves Model CGA-580 Sherwood. Lots Nos .: 03-00, 43-99, 48-99; Connector No. CGA 580 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Kendall Healthcare Products Co A Tyco Healthcare Group Co 에 의해 제조된 제품과 관련되어 있습니다.

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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
    228
  • 날짜
    2000-12-15
  • 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
    Airgas has been informed that the hospital gas cylinder valves of the aforementioned lots may have undergone too strong torque during assembly, resulting in damage to the threads. failures have been reported during filling of the cylinders with the aforementioned valves, and it is suspected that such failures may also occur during the provision of system pressurizing service. airgas declares that these failures have resulted in the separation of the valve protection registers and caps, strong enough to potentially cause serious injuries and property damage.
  • 조치
    Airgas recommends the following: (1) Check valves on all gas cylinders containing argon, helium, nitrogen and non-flammable gas mixtures, or any other cylinders equipped with defective valves. (2) If any cylinder is from Airgas, isolate the cylinders and identify them with a mark or label. (3) Contact your local representative or directly with Judy McCurry, Airgas, at 1 (916) 376-8515, ext. 2344, for them to be collected and replaced. (4) If a cylinder is connected to a pressurized system, with or without the valve opening, do not touch the cylinder or valve because the valve cap may be ejected. Isolate the area and contact your local representative or directly with Airgas, or your local supplier for assistance. For more information, contact Judy McCurry, Airgas, Correspondence at the above address, or call 1 (916) 376-8515, ext. 2344. ECRI notes that these cylinders may be used by hospital personnel for refrigeration, diagnostic imaging by magnetic resonance, medical and vacuum gas maintenance systems.