Events

DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121 / SN09000086, 426122 / SN09000092, 456396 / SN10000277, 483715 / SN11000504, 512026 / SN12000272, 514483 / SN13000004, 521862 / SN13000033 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH 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
    1502
  • 날짜
    2014-11-05
  • 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
    The company makes it clear that if the hook does not securely support the feet in an upright position, the support may fall and injure the operator or patient. #### UPDATED 7/18/2017, the company submitted field action proving the replacement of the part as planned.
  • 원인
    The platform for the entire column exams can be fixed in the upper position. when the clamp (hook) is not adjusted in its correct position, the foot support is not secured securely. if it falls, it may hurt the operator's or patient's foot (for example, when moving the stand or when the operator can not fix it correctly when moving the stand up). the following factors are necessary for this situation to occur: - hook not properly adjusted - operator does not recognize that the hook is not engaged in the correct place - patient support is moved (rotated) - hook is not secure - foot is in "risk area".
  • 조치
    The customer / user should always check the correct hook position and whether the hook is locked. (Press the hook down until it locks in place) Ensure that the hook is in the position shown in the figure with the green arrow (at the safety warning).

Device

DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA