Airsep Impulse Elite 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-2017-RN-01448-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-05
  • 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
    An oxygen conserving device (ocd) is subject to sudden and unpredictable failure when connected to a medical oxygen gas cylinder and pressurised. the cause of failure is due to fatigue and aging of the device as the device is now being operated outside the manufacturer's maximum recommended service life of 7yrs. failure consists of sudden localised pressure loss via the pressure gauge leading to mechanical damage. there is a small chance that this mode of failure could result in the device's outer casing breaking apart to a degree where small plastic projectiles could imact the patient depending on their proximity to the device at the time of failure. this make and model ocd (see above) was discontinued by the manufacturer (airsep) in late 2009 and no new units have been supplied to the market since that time.
  • 조치
    If you own an AirSep Impulse Elite OCD complete and return the supplied Facsimile Reply Form to arrange for the renewal of your OCD. Return the form even if you no longer have an AirSep Impulse Elite OCD or previously had one but are no longer in possession of it. If you have provided any units to other users please pass this letter onto them and inform Air Liquide. If you rent an AirSep Impulse Elite OCD from AIR LIQUIDE Healthcare, we will be contacting you shortly to arrange a suitable time to recover and replace this device with a newer make and model OCD. Affected units may continue to be used until swapped out subject to the precautions described in the letter to customers.

Device

  • 모델명 / 제조번호(시리얼번호)
    Airsep Impulse Elite Oxygen Conserving DeviceModel Number: OC006-3ARTG Number: 81737
  • Manufacturer

Manufacturer