Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty Ltd 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
    RC-2013-RN-00845-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-14
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Ge healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the tec 6 and tec 6 plus vaporizers. the low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers, resulting in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. a fresh gas leak in the vaporizer does not affect delivery of the set anaesthetic agent concentration but could result in a reduction in the volume of fresh gas delivered to the breathing system. this can lead to a reduction of flow of oxygen delivered to the patient, resulting in hypoxic gas concentrations and/or a reduction in the volume of anaesthetic agent delivered to the breathing circuit which may cause light anesthesia. the fresh gas leak may release nitrous oxide (n2o) gas into the ambient air and may result in clinician exposure.
  • 조치
    GE Healthcare is providing users with an addendum with directions to perform the low pressure test with the dial turned to 12%. Users are advised by GE to discontinue use of vaporizors if it fails at 12%. If the vaporizer passes, the device can continue to be used. GE will be repairing/replacing the seals on all Tec 6 and Tec 6 Plus vaporizers as a permanent fix in August 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
    Tec 6 and Tec 6 Plus Vaporizers (Used to vaporize anaethesic agent Desflurane)Manufactured between 12 August 2005 and 03 December 2012 (AETJ29001 to AESR49001)ARTG Number: 140207
  • Manufacturer

Manufacturer