Events

ConchaTherm Neptune heated humidifiers 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Teleflex 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
  • 사례 ID
    MDA/2012/068
  • 사례 연번
    CON185606
  • 날짜
    2012-09-25
  • 사례 출판 날짜
    2012-09-25
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON185606?tabName=allTabs
  • 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
    Potential for failure of the speaker. if the speaker fails, no alarm will sound in the event of a device failure, which could cause a delay in patient treatment. the manufacturer published a field safety notice (fsn), in june 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon. although the speaker failure will result in no alarm sounding if there is a problem, the humidifier will continue to detect any abnormalities and take appropriate action.
  • 조치
    Locate and identify all affected devices using the list of serial numbers in the manufacturer’s FSN. Check the speaker by following the instructions in the manufacturer’s FSN. Return the acknowledgement form to Teleflex. If faulty speakers are found, contact Teleflex immediately to request replacement speakers as a priority. For future use, be aware that if the humidifier makes neither an audible alert nor alarm as part of the self-check on startup, there may be a fault with the speaker.

Device

ConchaTherm Neptune heated humidifiers
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    ConchaTherm Neptune heated humidifiers. Product codes: 425–00, 425–10 and 425–30. Specific serial numbers. This heated humidification system is designed to heat and humidify respiratory gases delivered to adult and paediatric patients.
  • Manufacturer
    Teleflex

Manufacturer

Teleflex