Events

Device Recall Gamma X XL Portable Patient 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
    59568
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3048-2011
  • 사례 시작날짜
    2011-07-29
  • 사례 출판 날짜
    2011-08-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103117
  • 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
    Physiological Patient Monitor (with Arrhythmia Detection or Alarms) - Product Code MHX
  • 원인
    Monitor keys may spontaneously become inoperative or active. this may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
  • 조치
    Draeger Medical sent an "Urgent Medical Device Recall Notification" letters dated July 2011 to all affected customers. The letter included product and problem affected. The letter informed the customer a Draeger representative will contact them to upgrade the system. Until the solution is implemented, Draeger recommends the Delta and/or Gamma XXL may be used. If the affected monitors become inoperative or activate without user interaction, Draeger advises removing the monitor from service and contacting a Draeger representative. For questions or for information on this recall please call Draeger Service at (800) 543-5047 (press 1 at the prompt, then 2, then 32349).

Device

Device Recall Gamma X XL Portable Patient Monitor
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number(s): MS18597/MS18852 with serial numbers (US) 6001246076, 6001246575, 6001247173, 6001365874, 6001067474, 6001073681, 6001073779, 6001073877, 6001095176, 6001098966, 6001099466, 6001069472, 6001077080, 6001198466, 6001216679, 6001229674, 6001208082, 6001211782, 6001218178, 6001220086, 6001243676, 6001246771, 6001245968, 6001357179, 6001214877, 6001075679, 6001077178, 6001083180, and 6001095773.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - (USA) Nationwide distribution including the states of AK, FL, LA, MN, MS, MO, NJ, NC, OH, OK, PA, TN, TX, NC, NH, NJ, NY, WV, and WI; and the countries of Australia, Austria, Argentina, Bahrain, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Georgia, Greece, Hungary, Italy, Ireland, India, Kazakhstan, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Norway, Russian Fed., Romania, Saudi Arabia, Slovakia, Spain, South Africa, Switzerland, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
  • 제품 설명
    Infinity Gamma X XL Portable Patient Monitor. || Draeger Medical Systems, Inc. || 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