Events

ALL GAZE CYLINDERS 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
    5
  • 날짜
    2001-05-14
  • 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
    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.
  • 조치
    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

ALL GAZE CYLINDERS
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA