Events

Styker’s Berchtold F-generation LED lights 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-11-04
  • 사례 출판 날짜
    2014-11-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141104.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic styker’s berchtold f-generation led lights medical device manufacturer, medtronic, has issued a field safety notice (fsn) concerning certain styker’s berchtold f-generation led lights with affected model numbers of f528 (with a serial number smaller than 831800001526) and f628 (with a serial number smaller than 831710002819). there is the potential for electromagnetic interference (emi) between medtronic’s stealthstation axiem or fusion em technology and the abovementioned models of styker’s berchtold f-generation led lights. when the lights are positioned according to berchtold’s instructions for use – at a distance at least one meter from the patient – there is no interference. when the lights are positioned closer to the patient, the resulting emi causes the stealthstation axiem or fusion em system to cease tracking and display “red status”, which prevents navigation until the emi is removed. the testing confirmed that the stealthstation axiem/fusion system meets specification. if users have the devices with one of the affected serial number ranges above, they should consider limiting use of the axiem or fusion em system to rooms that do not have these lights installed. if no alternative room is available, customers are reminded to ensure use of the lights according to the berchtold instruction for use, maintaining a light head position at least one meter from the surgical site. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2014.

Device

Styker’s Berchtold F-generation LED lights
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Styker’s Berchtold F-generation LED lights
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH