Events

Aquilon series of nebulisers 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 AFP Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 연번
    MS35752
  • 날짜
    2018-05-29
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/aquilon-series-of-nebulisers---priority-1---for-immediate-action&id=71bf0a26-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • 데이터 추가 비고
  • 원인
    The hpra has been informed that the aquilon series of nebulisers have been placed on the european market without appropriate ce certification. as such their safety and performance cannot be assured. this safety notice is to alert users and healthcare professionals not to use these devices.
  • 조치
    The HPRA advises that users and healthcare professionals: 1. Examine your stock to determine if you have the affected devices. 2. Identify patients who may have the devices. 3. Stop using the device immediately and use an alternative nebuliser. 4. Forward a copy of this safety notice to all relevant personnel within your organisation or to any other organisations/persons to which/whom these devices have been transferred. 5. Report any adverse events/incidents associated with these devices to the manufacturer and the HPRA.

Device

Aquilon series of nebulisers
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Aquilon series of nebulisers - Priority 1 - For Immediate Action
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    HPRA