Events

Capnostat Sensor for etCO2 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Draeger Medical Systems Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    22734
  • 사례 시작날짜
    2018-03-21
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Draeger New Zealand Ltd, Unit 4, 24 Bishop Dunn Place, East Tamaki, Auckland 2013
  • 원인
    The manufacturer has determined that when the infinity m540 patient monitor with software versions vg4.1 and below is used in combination with the infinity mcable mainstream c02 (m11.1) revision 16 sensor, the infinity m540 patient monitor will reboot if the sensor enters a reduced accuracy mode. should the infinity m540 patient monitor reboot 3 times within a 10 minute period or less, the infinity m540 patient monitor will go into a fail-state, resulting in a resetting to factory defaults, losing patient settings and stored patient data.
  • 조치
    Software to be upgraded

Device

Capnostat Sensor for etCO2
  • 모델명 / 제조번호(시리얼번호)
    Model: Revision 16 of the Infinity MCable Mainstream C02 (M11.1), Affected:
  • Manufacturer
    Draeger Medical Systems Inc

Manufacturer

Draeger Medical Systems Inc