Events

FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BIRD PRODUCTS CORP SUB THERMO ELECTRON CORP. 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
    82
  • 날짜
    2001-02-02
  • 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 alarm failure risk is alert on the fans. these fans may not detect the pressure changes in accidental cases of extinguish or disconnect between the flow tubes for the child and the "sensor" interface. this occurs when the flow sensor to the child remain connected to the circuit. these fans may also fail to impose respirators when used with the sensor in tcpl simv mode, programmed for low assistance sensitivity. the manufacturer began this correction in letter of 28 september 2000.
  • 조치
    VERIFY THAT YOU HAVE RECEIVED THE IBRD CORRECTION NOTIFICATION LETTER ON SEPTEMBER 28, 2000, REGARDING THE CPUS A, BE MONITOR OF VOLUME; INSTALLATION INSTRUCTIONS AND BIRD PRODUCTS VERIFICATION SHEET. IDENTIFY AND ISOLE THESE PRODUCTS. AGENDE WITH THE IBRD TECHNICAL SERVICE TO COME TO YOUR ESTABLISHMENT TO CHANGE THE CPUSES OF EACH OF THESE FANS. THEN COMPLETE THE CHECK FORM AND RETURN IT TO THE IBRD, ADJUSTMENT DEPARTMENT, BY FAX (0021-1-760-778-7274) OR BY MAIL (TO ADDRESS: 1100 BIRD CENTER DR, PALM SPRINGS CA 92262-8099 USA ). FOR FURTHER INFORMATION CONTACT YOUR IBRD OR TELEPHONE REPRESENTATIVE (0021-1-760-778-7200

Device

FANS USED IN INTENSIVE NEO-NATAL / PEDIATRIC CARE: (1) VIP GOLD, (2) VIP STERLING

Manufacturer

BIRD PRODUCTS CORP SUB THERMO ELECTRON CORP.
  • Source
    ANVSANVISA