Events

Oxylog Emergency Transport Ventilators 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Draegerwerk AG & Co KGaA 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
    20936
  • 사례 시작날짜
    2016-12-15
  • 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
    In december 2015 the manufacturer informed of an error condition obser with the oxylog 3000 and oxylog 3000plus, where the loss of contact of one of the control knobs generated an error message (previously referred to as poti unplugged). in these cases, acoustical and visual alarms are triggered, the breathing system releases pressure and the ventilation function stops operating. the error condition was caused by an oxide layer in the potentiometer. oxide layers may accumulate over a longer period of time if various factors collude i.E. if the knobs are moved rarely or never. a verified remedy is repeated twisting of the knobs that removes the oxide layer. remedy of twisting the knob is still considered effective however, to reduce the impact of this error condition the manufacturer has developed new software that reduces the impact of the error condition.
  • 조치
    Software to be upgraded

Device

Oxylog Emergency Transport Ventilators

Manufacturer

Draegerwerk AG & Co KGaA