Events

O-arm 1000 Imaging Systems 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
    2018-09-10
  • 사례 출판 날짜
    2018-09-10
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180910.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 o-arm 1000 imaging systems medical device manufacturer, medtronic, has issued a medical device safety alert concerning all 2nd edition o-arm 1000 imaging system. the affected devices are identified as follow: product names (catalogue number) oarm assy bi70000027 system product (bi70000027) oarm assy bi70000027r sys product rwk (bi70000027r) base oarm bi70000027100 system 100v (bi70000027100) base oarm bi70000027100r system 100v rwk (bi70000027100r) base oarm bi70000027120 system 120v (bi70000027120) base oarm bi70000027120r system 120v rwk (bi70000027120r) base oarm bi70000027230 system 230v (bi70000027230) base oarm bi70000027230r system 230v rwk (bi70000027230r) oarm assy bi70000027ger sys product ger (bi70000027ger) oarm assy bi70000027gerr sys product refurb (bi70000027gerr) the manufacturer released software version 3.1.7. the change is in response to customer complaints and addresses several known software anomalies. the software anomalies were reported to affect the following system functionalities: startup and shutdown system and network communication motion control image acquisition and output dose reporting logs generation according to the manufacturer, over the last six years, five complaints led to cancelled procedures after the patient was under anaesthesia requiring additional surgery. the field action is being initiated to address the issues relating to these complaints. the local supplier will contact affected users to schedule completion of the software install. the affected users may choose to continue to use their 2nd edition o-arm 1000 imaging system at their clinical discretion in the meantime, but they should be aware of the issues described above, which may result in a delayed surgery, patient exposure to non-navigated surgery, patient exposure to additional surgery or unused x-ray dose. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 10 september 2018.

Device

O-arm 1000 Imaging Systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic O-arm 1000 Imaging Systems
  • 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