Events

NIM non-invasive nerve monitoring equipment Medtronic Xomed 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Advance Biopolymers S.R.L 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
    I1606-267
  • 사례 연번
    2009DM-0003762
  • 날짜
    2016-06-30
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer who has identified a problem with excessive flexing of the tube by the user, especially at a sharp or abrupt angle, can cause the electrode wires to flow into its channel in the silicone wall, leading to potential adverse events occurring in patients.

Device

NIM non-invasive nerve monitoring equipment Medtronic Xomed
  • 모델명 / 제조번호(시리얼번호)
    Endotracheal Tube of EMG Reinforced NIM Standard and Contact, models 8229306, 8229307, 8229308, || 8229506, 8229507 and 8229508, specific lots.
  • 제품 설명
    This device is intended for the supervision of surgical procedures for patients who require intraoperative monitoring of nerves, whose nature is non-invasive, assisting the surgeon in the location and mapping of the motor nerves through the use of EMG signals and electrical nerve stimulation. This equipment is accompanied by a series of accessories that connect to the patient in order to carry out the follow-up through the different measurements that the device performs.
  • Manufacturer
    Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Advance Biopolymers S.R.L

Manufacturer

Medtronic Xomed, Inc || Medtronic Xomed Instrumentation S.A.S || Medtronic Xomed Inc. || Fidia Ad...
  • Source
    NIDFSINVIMA