Non-invasive extra-thoracic ventilators Respironics, model NEV-100 의 안전성 경고
Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는
Brazil
에서 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.
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
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
원인
All units manufactured between april 1992 and february 1999. a circuit failure may cause the above respirators to stop, shut down, and do not restart and / or exhibit smoke or smoke smell. the manufacturer initiated the correction by letter dated may 24, 1999.
조치
Check receipt of the letter dated May 24, 1999 from Respironics. Discontinue use of the product as soon as possible. Your local Respironics representative should have contacted you to arrange the repair of the affected ventilators. If it has not already done so, call one of the numbers below and Respironics will help you have your ventilator (s) serviced at no charge. The manufacturer states that this correction must be completed by the end of 2001. For more information, contact your local representative or Respironics at 1 (412) 731-2100 (United States).