Events

Single Use Breathing Circuit with Flow Sensor for OSIRIS3 Emergency Ventilator 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Air Liquide Medical Systems SA 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
  • 날짜
    2011-02-22
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/circuit-respiratoire-usage-unique-avec-capteur-de-debit-pour-ventilateur-d-urgence-osiris3-air-liquide-medical-systems-s-a--rappel-de-lot
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    Air Liquide Medical Systems SA has withdrawn batches 101151977 and 110152448 from the reference KG020000 of the medical device called: Single-use breathing circuit with flow sensor for emergency ventilator OSIRIS3, manufactured by Flexicare (UK). Indeed, the two lots concerned were equipped with the wrong reference flow sensor. The flow measurement performed is reduced. This induces errors on the measurement of the expired volume of the order of 20% (lower volume). . Air Liquide Medical Systems SA has directly notified the recipients of the incriminated lots by means of the message attached (22/02/2011) (35 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities will be informed of this measure by the manufacturer.

Device

Single Use Breathing Circuit with Flow Sensor for OSIRIS3 Emergency Ventilator

Manufacturer

Air Liquide Medical Systems SA