Events

GE Anaesthesia Work Stations 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Datex-Ohmeda 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
    19945
  • 사례 시작날짜
    2016-03-24
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 원인
    It has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all aisys cs2 and upgraded aisys anesthesia devices. aisys cs2 anesthesia devices and upgraded aisys anesthesia devices deliver a momentary, self-correcting increase of the anesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes: a fresh gas setting change from 95%-25% oxygen to only air (21% oxygen). any total flow setting change while using 21% oxygen (air only). the momentary bolus of anesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). delivery of this momentary bolus of anesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable pediatric patients when 21% oxygen (air only) is used. there have been no injuries re ported of this issue.
  • 조치
    Software to be upgraded

Device

GE Anaesthesia Work Stations
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected:
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc