Events

Device Recall Puritan Bennett 840 Series Ventilator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nellcor Puritan Bennett Inc. (dba Covidien LP) 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
    67163
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0821-2014
  • 사례 시작날짜
    2013-01-25
  • 사례 출판 날짜
    2014-01-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124803
  • 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
    Covidien is correcting labeling to clarify the operational life of the oxygen sensor (o2 sensor), pn 4-072214-00 used in the puritan bennett" 840, and pn, g-062010-00, used in puritan bennett" 740, and760 ventilator systems. the operators manual for pb840 states a nominal life of one year and the addendum incorrectly states 2 years.
  • 조치
    The firm, Covidien, sent an "URGENT MEDICAL DEVICE VOLUNTARY FIELD CORRECTION" letter dated January 24, 2014 to its Consignees/customers via certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to read and understand the enclosed information; communicate this information to those who need to be aware of this labeling update; for the Puritan Bennett 840 ventilator only: If you have addendum P/N 066009A 09/02, remove and discard the addendum and replace it with the new information in Attachment I; for the Puritan Bennett 740 and 760 ventilators only: Add the new information in Attachment I; Ensure all O2 sensors in use or in inventory conform to the instructions in this notification. to your current operators manual and service manual, and read and understand the warnings, cautions and notes related to safety, ventilator use and operation that are contained in the Preface of the Operators Manuals. are asked to remove incorrect labeling and replace with the revised labeling. Covidien enclosed a labeling update (Attachment I) which provides detailed information related to the life of oxygen sensors used with the Puritan Bennett 840, 740 and 760 ventilators. Covidien has validated another oxygen sensor, P/N 10097559, for use in the Puritan Bennett 840, 740 and 760 ventilators. Information about that sensor is also included in the update in Attachment I. Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840, 740 or 760 ventilators contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed.

Device

Device Recall Puritan Bennett 840 Series Ventilator
  • 모델명 / 제조번호(시리얼번호)
    PB840 Operators Manual Addendum: PN 066009A 09/02
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.
  • 제품 설명
    Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 || The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • 제조사 주소
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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