Events

Flowi Anesthesia System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Maquet Cardiovascular Us Sales, Llc 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
    71054
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1706-2015
  • 사례 시작날짜
    2015-04-02
  • 사례 출판 날짜
    2015-06-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-07-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135941
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • 원인
    In some flow-i anesthesia systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
  • 조치
    The firm, Maquet Inc., sent an "Urgent Medical Device Field Action Field Correction for FLOW-i Anesthesia Systems" letter dated 4/2/2015 via FedEx. The letter describes the product, problem and actions to be taken. The customers were instructed to read the letter and inform staff, who may use the FLOW-i Anesthesia System of the patient cassette locking device issue. Customers are to obtain the serial number of their system; verify the serial number obtained against the serial number listed in the box in the Appendix. A Maquet Service Representative will be contacting you to arrange a convenient time to replace your FLOW-i Anesthesia System patient cassette locking device. If you have any questions regarding this field action, please contact your Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (Press option 3, followed by option 1 and then option 1 again), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EST.

Device

Flowi Anesthesia System
  • 모델명 / 제조번호(시리얼번호)
    Article number 66 77 200 66 77 300 66 77 400  Serial Numbers 1058 1646 2034 2723 1059 1647 2095 2724 1060 1648 2186 2729 1172 1650 2554 2731 1201 1651 2555 2732 1202 1652 2556 2733 1204 1653 2557 2735 1224 1654 2558 2736 1225 1655 2559 2737 1226 1656 2560 2738 1277 1657 2561 2739 1280 1786 2562 2740 1281 1787 2613 2741 1282 1860 2714 2742 1545 1861 2716 2743 1546 2021 2719 2744 1643 2022 2720 2745 1644 2023 2721 2746 1645 2024 2722 2747
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Libya, Mexico, Mongolia, Mozambique, Netherlands, Norway Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Unites States, and Venezuela.
  • 제품 설명
    FLOW-i Anesthesia System || The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • 제조사 주소
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA