Events

Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 YSM Medical & Rehabilitation Equipment Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 연번
    SN2009(12)
  • 날짜
    2009-12-10
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/oxy-top-5-oxy-tec-5-oxygen-concentrator&id=548cf825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
  • 조치
    Advice for Retailers and Wholesalers  (1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.  (2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  (3) Ensure the appropriate personnel are made aware of this notice.  Advice for Healthcare Institutions / Consumers  (1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.  (2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.  (3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.  (4) Ensure the appropriate personnel are made aware of this notice.

Device

Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator

Manufacturer

YSM Medical & Rehabilitation Equipment Ltd
  • Source
    HPRA