Events

Dameca Anaesthesia Machines 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Dameca A/S 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
    18161
  • 사례 시작날짜
    2015-03-05
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    If the patient is connected to the anaesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure, around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical negative pressure limiter (npl) valve. the npl valve opens if the patient generates a negative pressure of -5 and -7.5 cmh20 (hpa). this opening pressure of the npl valve is defined at an inspiratory flow rate of 3.5-4.5 l/min. if the patient creates a higher flow rate than 4.5 l/min, the npl valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further.
  • 조치
    Instructions for use to be updated

Device

Dameca Anaesthesia Machines
  • 모델명 / 제조번호(시리얼번호)
    Model: IntelliSave AX700 (866205/10623-00), Dameca MRI508 (866203/10651MRI-00), Siesta iWhispa (866202/10651-00), Siesta iTS (866163/10653-00), Siesta Breasy (866204/10652-00), Affected: All serial numbers
  • Manufacturer
    Dameca A/S

Manufacturer

Dameca A/S