Events

Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Acutronic Medical Systems AG 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
    Safety alert / Field Safety Notice
  • 날짜
    2018-12-21
  • 사례 출판 날짜
    2018-12-21
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/fabian-ncpap-evolution-fabian-therapy-evolution-and-fabian-hfo-risk-of-total-loss-of-patient-ventilation-mda-2018-037
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Manufactured by acutronic medical systems ag – ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
  • 조치
    Identify all affected ventilators – see the Problem section of this alert or the manufacturer’s Field Safety Notices (FSNs) reference FSCA 18-003 and FSCA 18-004. Use an alternative ventilator for treatment if available. If no alternative is available, carry out – and document – a risk assessment based on a clinical risk-benefit analysis before using the ventilator. If you continue to use an affected ventilator, make sure you follow the instructions in the manufacturer’s FSNs and be extra vigilant. Disconnect any ethernet connections from the device. All affected ventilators that have unexpectedly shut down or had power cycling should be removed from service. Complete the End User Response form(s) and return to Kevin.Nash@inspiration-healthcare.com. If you are affected by both FSNs, you must return both forms. Report any incidents or complaints involving this product to info@acutronic-medical.ch

Device

Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO

Manufacturer

Acutronic Medical Systems AG
  • 제조사 주소
    Acutronic Tel: +41 44 729 70 80info@acutronic-medical.chUK Distributor contacts Inspiration Healthcare Kevin Nash, Quality and Compliance Engineer Tel: 0127 352 6504 Kevin.Nash@inspiration-healthcare.com
  • 제조사 모회사 (2017)
    Acutronic Medical Produktion Ag
  • Source
    MHRA