Events

CRYOGENIC HOSPITAL GAS CYLINDERS; (2) OXYGEN SUPPLY SYSTEMS (3) HOSPITAL GAS VALVE CONNECTORS) 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
    103
  • 날짜
    2001-07-20
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The fda issued on july 20, 2001, a public health alert that warns health establishments of the potential for patient aggravations when cytogenetic gas cylinders are mistakenly connected to o2 supply systems, patients receive other gas, such as nitrogen, other than medical o2. fda received report on 7 orbits and 15 aggregates, over the last 4 years, related to the erroneal connection of hospital gas in intensive therapy units and domiciliary attention units.
  • 조치
    ACTION REQUIRED: The FDA RECOMMENDS THAT ALL OPPORTUNITIES TO PROMOTE THE PROPER HANDLING OF HOSPITAL GASES, AS WELL, OF RELATED CYLINDERS AND CONNECTORS, ARE ACCEPTED. TO THE FOLLOWING: (1) WHEN CONNECTING A CYLINDER, CAREFULLY EXAMINE THE LABEL TO ENSURE THAT THE GAS CONTAINS THE GAS ADEQUATE TO ITS APPLICATION, TO AVOID POSSIBLE AGGREGATES ARISING FROM ERRONE CONNECTION OF HOSPITAL GAS CYLINDERS. (2) NEVER USE ADAPTERS OR CHANGE CONNECTORS OR PLUG IN A CYLINDER. IF A CONNECTOR DOES NOT JOIN THE O2 SUPPLY SYSTEM, PROBABLY THE GAS IN WHICH CYLINDER IS NOT O2 AND, THEREFORE, SHOULD NOT BE USED. (3) MAKE SURE THAT ALL PERSONNEL HANDLING HOSPITAL GASES ARE PROPERLY TRAINED AND UNDERSTAND THE OPERATIONS AND CONNECTIONS OF HOSPITAL GAS SYSTEMS AND LABELS. (4) IF YOUR ESTABLISHMENT RECEIVES BOTH HOSPITAL AND INDUSTRIAL GASES, STORE IN SEPARATE LOCATIONS. TO REPORT ADVERSE EVENTS RELATED TO HOSPITAL GASES, CONTACT THE MANUFACTURER OF THE CYLINDER, OR SEND CORRESPONDENCE TO ANVISA, ON THE INTERNET WWW.ANVISA.GOV.BR/TECNOVIGILÂNCIA/ FORMS OR BY THE E-MAIL TECNOVIGILANCIA@ANVISA.GOV.BR

Device

CRYOGENIC HOSPITAL GAS CYLINDERS; (2) OXYGEN SUPPLY SYSTEMS (3) HOSPITAL GAS VALVE CONNECTORS)
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA