Events

Nellcor Durasensor® (DS-100A) sensors Product Code: DS-100A 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Tyco Healthcare group LP 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
    SN2011(01)
  • 날짜
    2011-01-21
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-covidien-nellcor-spo2-durasensor-(ds-100a)-sensors&id=1589f825-9782-6eee-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
    The supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • 조치
    The IMB advises that:  • All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit identify, locate and quarantine all product to ensure it will not be used.  • If you identify that you have product that is counterfeit you should submit the information detailed in Appendix I to theHPRA (enforcement@hpra.ie). On receipt of this information the IMB will contact you to advise what further course of action is required.

Device

Nellcor Durasensor® (DS-100A) sensors Product Code: DS-100A
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors
  • Manufacturer
    Tyco Healthcare group LP

Manufacturer

Tyco Healthcare group LP
  • Source
    HPRA