Events

BrightView XCT Image System, Registration No. 10216710189, Serial Nos: 6000109, 6000115, 6000126, 6000276. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda. 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
    1307
  • 날짜
    2013-10-11
  • 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
    The company informs that if the FDP unexpectedly unlocks, it can potentially contact the patient, the operator or the service personnel if they are in the path of the FPD. The severity was classified as "results in serious harm" and the likelihood of recurrence was classified as "not expected".
  • 원인
    Philips received a report from the field that the fpd was not firmly locked in the lodged position. a warning system message appeared warning the user that the fpd was unlocked. according to the project, the unlocking of the fpd caused the activation of the electronic stop by the system. in an attempt by the operator to eliminate the warning message while in the 0 degree position, the fpd has moved out of the lodged position.
  • 조치
    Philips Healthcare is advising the customer / user to keep the FPD in place until the appropriate field safety correction is implemented. The following seven Pre-Programmed Movements (PPMs) can not be performed with the FPD positioned and are therefore unavailable until the field security correction is implemented: i. Bed Imaging (Mega-Body Scan), ii. Subsequently, iii. Seated Plantar, iv. Outer Room, v. DH Hands, vi. DH Sitting, vii. DH Standing. The following two PPMs must be performed with the FPD housed, so the operator must be careful: • Collimator exchange - To make a collimator change, the operator must first house the FPD. There should be no patient present during the collimator change as instructed in the Instructions for Use. • Intrinsic QA - This PPM requires that the FPD be in the housed position. There should be no patient present during the intrinsic QA. In addition, if the FPD unlocks without this being intended by the user in any position except the +90 degree position, a system warning will appear informing the user that the FPD is unlocked and that all movement will cease. • If the system is in clinical use at the time the warning message appears, the user must manually remove the patient from the area before attempting to lock the panel again. Refer to the current System Use Instructions Manual, "Removing a Patient from Gantry during an Emergency." • The user is instructed not to attempt to position or place the FPD in any position except the +90 degree position. Refer to the WARNING message located in the Flat Panel X-ray Detector (FPD) section of your current system INSTRUCTION MANUAL. Please refer to the Safety Notice letter attached to this alert.

Device

BrightView XCT Image System, Registration No. 10216710189, Serial Nos: 6000109, 6000115, 6000126,...

Manufacturer

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