Events

O-arm Imaging Systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
  • 날짜
    2013-01-28
  • 사례 출판 날짜
    2013-01-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130128a.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 imaging systems medical device manufacturer, medtronic ltd., has issued a field safety notice concerning o-arm imaging systems. the affected serial numbers are from 101 to 564. the manufacturer has identified a potential failure in the braking system that controls the o-arm gantry’s vertical movement. this potential failure exists when the o-arm gantry is in a raised position, and could result in an uncontrolled descent when the up/down button is released. the gantry would stop when coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel (which could include contact with the patient and/or protruding instrumentation within the bore of the system). according to the manufacturer, this potential failure has no impact on the amount of radiation emission delivered by the system, and there have been no reports of this or similar events occurring at any customer site. if the transistor component fails, the gantry could experience an uncontrolled descent until coming to rest on the hard stop on the horizontal frame of the device or reaching the end of travel. the falling gantry could contact the patient, or protruding instrumentation within the bore of the system. this has the potential to result in serious injury or death to the patient, or injury to users, or both. the manufacturer will implement an improved circuit for the braking system that controls the o-arm gantry’s vertical movement. this improved circuit will be implemented by replacing the motion control box on all affected o-arm imaging systems. furthermore, the manufacturer advises that the risk of the adverse health consequences described can be reduced by setting the or table/patient height from the floor as low as possible. according to the local supplier, medtronic international limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 january 2013.

Device

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

Manufacturer

Medtronic 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
    DH