Events

Puritan Bennett 800 Series Ventilator System 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Covidien LP 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2014-03-02
  • 사례 출판 날짜
    2014-02-28
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2014/02/28/vazno-obavestenje-o-medicinskom-sredstvu-3/
  • 비고 / 경고
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • 데이터 추가 비고
  • 원인
    Puritan bennett 840 fan users have been provided with conflicting information in the marking supplement (cat. no. 066009a 09/02) that the oxygen sensor should be replaced every two years. the correct useful life is one year from the date of manufacture, as stated in the puritan bennett 840 fan operator's manual. sensor, cat. no. 4-072214-00 sensor kit, pn g-062009-00, should not be used after the expiration date indicated on the oxygen sensor package. the puritan bennett 700 series owner's manual and service instructions also state that the oxygen sensor should be replaced every two years. sensor, cat. no. g-062010-00 i sensor kit, pn g-062009-00, should not be used after the expiration date marked on the oxygen sensor package.

Device

Puritan Bennett 800 Series Ventilator System
  • 모델명 / 제조번호(시리얼번호)
    cat.num. 066009A, 4-072214-00, G-062010-00, G-062009-00
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • 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
    ALIMSA