Events

AirSep Impulse Elite OCD (oxygen conserving device) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Air Liquide Healthcare 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-00462-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00462-1
  • 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
    It has been determined that there is a weak spot in the solder joint at the pressure gauge which may cause the development of a gas leak from this area. in extreme cases, there is a small chance that the pressure gauge may suddenly fail resulting in an uncontrolled release of a small volume of high pressure oxygen accompanied by a loud "bang" sound.
  • 조치
    End users are requested to notify Air Liquide Healthcare if they have an affected AirSep Impulse Elite OCD. Air Liquide Healthcare will arrange for the replacement of the unit. Affected units can continue to be used in the interim. To minimise any adverse operation of your Impulse Elite OCD end users are requested to ensure the following steps are taken: - listen for gas leaks emanating from the OCD. Adjust the OCD on the cylinder valve. Should the leak persist, discontinue use and contact AIR LIQUIDE Healthcare customer service. - ensure when replacing the OCD between cylinders to minimise, where possible, standing over or placing you head in close proximity to the pressure gauge. If this is required to read the gauge, then keep the duration of this inspection as short as possible. For further details, http://www.tga.gov.au/safety/alerts-device-airsep-impulse-elite-130723.htm

Device

AirSep Impulse Elite OCD (oxygen conserving device)
  • 모델명 / 제조번호(시리얼번호)
    AirSep Impulse Elite OCD (oxygen conserving device)Model number: OC006-3Serial number between 088102 and 101360
  • Manufacturer
    Air Liquide Healthcare Pty Ltd

Manufacturer

Air Liquide Healthcare Pty Ltd