Events

Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series numbers affected in Brazil-distributed in the Municipality of São Paulo-SP: 99; 142; 144; 145 distributed in the Municipality of Rio de Janeiro-RJ: 239; 241; 243. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET 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
    1856
  • 날짜
    2016-04-14
  • 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
    Recommendations to users and patients: Check at the time of use of the equipment whether the basic table top is locked on the conveyor or if it needs to be transferred to the conveyor, make sure that the extension device is attached to the side opposite the battery holder and conveyor belt bar. ### UPDATED ON 04/09/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • 원인
    Maquet within the scope of market surveillance has learned that, due to improper handling under unfavorable circumstances, the magnus 1180 table extension device can be unlocked from the tabletop and fall. this problem may occur when the device is not used according to the description in the instructions for use and the operator does not pay attention to possible collisions. in extreme cases, collisions with an obstacle under the tabletop can lead to the problem described above. the extension device may from the operating table mounting point if: • the table top with mounted accessories is moved against obstacles; • the assembled table top with accessories is transferred to the conveyor incorrectly with the foot and head ends inverted.
  • 조치
    Code of the action CAPA 2016-002. Send of letter of report for the customers that have equipment affected ////// Sending of technicians to the place of equipment affected for installation of new accessory.

Device

Trade Name: SURGICAL TABLE; Model MAGNUS 1180; registration: 80259110066; risk class I; Series nu...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MÉDICOS LTDA.; MAQUET GMBH