Events

Newport e360 Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Newport Medical Instruments Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58620
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2468-2011
  • 사례 시작날짜
    2009-10-27
  • 사례 출판 날짜
    2011-06-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99720
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Ventilator, continuous, facility use - Product Code CBK
  • 원인
    Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
  • 조치
    Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require additional information, please call (714) 427-5811 extension 344.

Device

Newport e360 Ventilator
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: N09360914600, N09360914601, N09361014775 - N09361014786, N09361014874 - N09361014877
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including states of CA, KY, and Silver City, New Mexico and country of Quito, Ecuador.
  • 제품 설명
    Newport e360 Ventilator, Model Number: e360 || The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • 제조사 주소
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • 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
    USFDA