Events

Device Recall Infinity Delta/Gamma X XL Portable Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draeger Medical Systems, 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
    55870
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2283-2010
  • 사례 시작날짜
    2010-06-04
  • 사례 출판 날짜
    2010-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92106
  • 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
    Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) - Product Code MHX
  • 원인
    Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. this may discharge a patient automatically.
  • 조치
    Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.

Device

Device Recall Infinity Delta/Gamma X XL Portable Monitor
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: MS18597
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WO, and W, and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Benin, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Serbia, Czech Republic, Germany, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Coratia, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon,Lithuania, Latvia, Libya, Morocco, Macedonia, Martinique, Mexico, Netherlands, Norway, Nepal, Peru, Poland, Puerto Rico, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovak Republic, Turkmenistan, Turkey, Ukraine, Uruguay, Venezuela, Mayotte and South Africa. The government accounts are Bay Pines VAMC, Bay Pines, FL; Naval Medical Center, Portsmouth, VA; and Walter Reed Army Medical Center, Washington, DC.
  • 제품 설명
    Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

Draeger Medical Systems, Inc.
  • 제조사 주소
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA