Events

X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Registry: 10216710191; ///. . Ingenuity CT, Record: 10216710209; ///. Serial numbers: 58524531; 5,877,142; 61676906; 61701347; 61877637; 61965826; 6,213,815; 62218321; 62829796; 6,308,7087; 63090577; 6,374,4537; 63820666; 63842205; 63912144; 63929459; 64046882; 64075140; 62506739. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. 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
    1508
  • 날짜
    2015-02-11
  • 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
    According to the record holder, there were no reports of injuries due to this failure mode, but when the vertical brake malfunctions, the technician, patient or other users who are near the table may suffer an injury.
  • 원인
    According to the registry holder there is a possible vertical brake failure, which may lead to uncontrolled movement of the patient's bed. there are no reports of users being injured.
  • 조치
    The record holder's recommendations, in the event of an uncontrolled vertical movement of the patient's bed, the use of the equipment should be discontinued and the user should contact the local care provider. The company does not guide stopping in the use of the bed. Users who prepare and operate the system with the patient should be aware while the patient is on or near the Patient Bed, especially in the case of intubated patients or in similar situations. These guidelines must be followed until the equipment is corrected.

Device

X-ray System for Computed Tomography ,; Brand Philips; Risk class III; models:. . Brilliance, Reg...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA