Events

Pulmonary Ventilator, models Trilogy 202 / Trilogy 100 / Trilogy 200, registration 10216710280 and 10216710291, risk class III, serial numbers affected (SEE ANNEX). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Respironics, 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
    1808
  • 날짜
    2016-01-21
  • 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
    Philips will shortly release the updated device software to avoid the problem described above. Updated device software will be available at my.respironics.com. Customers of this product will receive a letter stating the availability of the updated software. /// The registry holder has been reinforced by the need for users to verify the correct prescription for their therapy session, displayed in the upper left corner of the Trilogy screen.
  • 원인
    Philips respironics has learned that trilogy fans, with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01, are susceptible to an accidental change in prescriptions. this can occur under a certain set of operating conditions and after a specific sequence of keystrokes without requiring the user to confirm the change. the devices continue to display precisely the active prescription in the upper left corner of the screen. since this change in prescription was accidental and no confirmation was required, the user may not have noticed this change.
  • 조치
    Field Correction by releasing the updated software from the device to avoid the problem described above. The updated device software will be available at my.respironics.com //// Recommendations to users and patients: 1. Complete and return the Business Response Form. 2. Affected devices may continue to be used in accordance with the Device Instructions for Use and this Safety Notice. 3. Notify users with affected devices of the following: - Check the correct prescription for your therapy session, displayed in the upper left corner of the Trilogy 4 screen. In accordance with your usual operating procedures and / or maintenance schedule, update the device software as it becomes available. (Field Action: FSNR-01-2016-A)

Device

Pulmonary Ventilator, models Trilogy 202 / Trilogy 100 / Trilogy 200, registration 10216710280 an...

Manufacturer

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