Events

Humidifier 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Fisher & Paykel Healthcare Limited 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
    I1607-298
  • 사례 연번
    2014DM-0011418
  • 날짜
    2016-07-26
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer affirms that it will update the operation instructions of the referenced devices in order to include the verification to verify that the sound of the alarms is audible before use in each patient, ensuring the correct operation of the speaker, leading to prevent them from arising. possible adverse events on patients.

Device

Humidifier
  • 모델명 / 제조번호(시리얼번호)
    AIRVO 2 and myAIRVO 2, References PT101xx and PT100xx, serial 120521yyyyyyy until 160605yyyyyyy.
  • 제품 설명
    The MY AIRVO 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of high-flow heated and humidified respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The MY AIRVO 2 should be used in patients at home or in long-term care centers. The AIR 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of heated and humidified high-flow respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The AIRVO 2 should be used in hospitalized patients or in long-term care centers.
  • Manufacturer
    Fisher & Paykel Healthcare Limited

Manufacturer

Fisher & Paykel Healthcare Limited