Events

Legendair and Supportair Portable Ventilators 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Airox 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/2012/044
  • 사례 연번
    CON172306
  • 날짜
    2012-07-12
  • 사례 출판 날짜
    2012-07-12
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172306?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 the ventilator’s internal battery to fail. this can result in non-ventilation of the patient. this is due to failure of a capacitor (c53) on the printed circuit board (pcb). the ventilator will still function on external battery power and mains power. the manufacturer published a revised field safety notice (fsn) (see appendix) in july 2012 to revise the action required. the manufacturer did not receive confirmation from users that they had received and acted upon the information in the first fsn published in april 2012.
  • 조치
    Locate and identify all affected ventilators. For ventilator dependent patients, contact the manufacturer for a replacement PCB and fit this as soon as possible, as per the FSN (see appendix). For non-ventilator dependent patients, contact the manufacturer for a replacement PCB (or C53 capacitor, if PCB is unavailable) which should be fitted no later than the next scheduled service, as per the FSN. In the interim, users should ensure that affected ventilators are kept on mains power, or if required for transport, that an external battery is used and a back up ventilator is available. Inform Covidien when the PCB or capacitor has been replaced for all your affected units. Be aware that the PCB or capacitor should be replaced on an annual basis as part of the revised annual preventative maintenance schedule. Ensure procedures are revised, if applicable.

Device

Legendair and Supportair Portable Ventilators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Legendair and Supportair Portable Ventilators. Specific ventilator codes (see FSN). Supplied by Airox and Covidien. These ventilators are designed primarily for use by patients at home. The affected ventilator codes are as follows: Legendair™ Single Branch 4095700 - INTL LEGENDAIR SINGLE BRANCH 4095701 - GB NO LEGENDAIR SINGLE BRANCH 4095702 - DE LEGENDAIR SINGLE BRANCH 4095705 - CA LEGENDAIR SINGLE BRANCH 4095706 - JP LEGENDAIR SINGLE BRANCH 4095709 - DK LEGENDAIR SINGLE BRANCH 4095721 - AU LEGENDAIR SINGLE BRANCH Legendair™ Double Branch 4095900 - INTL LEGENDAIR DOUBLE BRANCH 4095901 - GB NO LEGENDAIR DOUBLE BRANCH 4095902 - DE LEGENDAIR DOUBLE BRANCH 4095905 - CA LEGENDAIR DOUBLE BRANCH 4095906 - JP LEGENDAIR DOUBLE BRANCH 4095909 - DK LEGENDAIR DOUBLE BRANCH 4095921 - AU LEGENDAIR DOUBLE BRANCH Supportair™ 4096200 - INTL SUPPORTAIR 4096201 - GB SUPPORTAIR 4096202 - DE SUPPORTAIR
  • Manufacturer
    Airox

Manufacturer

Airox
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA