Events

Commercial name: Intra-Operative Magnetic Resonance Imaging System Polestar N30 //// ANVISA record: 10339190462 /// Risk class: II. Affected model (s); PoleStar N-30 Systems and Batch (s) / Serial Number (s) Affected. One unit of system no. 3122 (distributed to São Paulo-SP). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MEDTRONIC COMERCIAL LTDA; MEDTRONIC NAVIGATION ISRAEL, LTD. 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
  • 사례 ID
    1928
  • 날짜
    2016-06-28
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    Recommendations to Users and Patients: Share this Urgent Security Notice with all those who work at your facility and use the PoleStar Surgical MRI System to have Medtronic perform an on-site inspection to verify and correct the ground connection on your PoleStar N -30. #### UPDATED ON 7/24/2017, Medtronic filed the field action completion report, verifying that the customer safety notice and equipment repair were submitted.
  • 원인
    Recently, in conducting internal tests, medtronic has identified a possible ground discontinuity in these subassemblies (warning light box and coolers), leading to a possible risk of electric shock to the user when in direct contact with these subsets. the risk assessment carried out concluded that the risk of electric shock to the user is low. in addition, the residual risk levels of the system have not changed and remain acceptable. in the medtronic risk assessment, there was no change in the risk to the patient since the assemblies were located outside the operating room. medtronic took immediate action to review and correct this problem. medtronic will perform an on-site inspection to verify and correct the ground connection on your polestar n-30 system.
  • 조치
    Correction in Parts and Parts Field /// Recommendations to users and patients. Action code FA725.

Device

Commercial name: Intra-Operative Magnetic Resonance Imaging System Polestar N30 //// ANVISA recor...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC NAVIGATION ISRAEL, LTD.
  • 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
    ANVSANVISA