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
    SN2010(17)
  • 날짜
    2010-12-22
  • 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-22.12.2010&id=9f89f825-9782-6eee-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 potential 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, quarantine the product to ensure it will not be used and contact your local Covidien representative, who will be able to confirm if the product is authentic.  • If you identify that you have product that is counterfeit you should return any such affected product in your possession to the local Covidien representative and inform the IMB.  Further Information: All adverse incidents relating to a medical device should be reported to the:  Irish Medicines Board  Kevin O’Malley House  Earlsfort Centre  Earlsfort Terrace  Dublin 2  Telephone: +353-1-6764971  Fax: +353-1-6344033  E-mail: vigilance@HPRA .ie  Website: www.HPRA .ie  Enquiries should be addressed to:  Local Covidien Office:  Deirdre O’Connor at: 087 8168519  Mark Gray at: 087 6538087  Covidien Ireland  Block G, 1st Floor  Loughlinstown  Dublin  Please click here to download a pdf version of the safety Notice « View List Latest Information Provide Feedback   Page Attachments  - Advisory - Counterfeit Covidien Nellcor SpO2 RSS Feeds HPRA Notices RSS Feed

Device

Nellcor Durasensor® (DS-100A) sensors\Product Code DS-100A
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Counterfeit Covidien Nellcor SpO2 Durasensor® (DS-100A) sensors 22.12.2010
  • Manufacturer
    Tyco Healthcare group LP

Manufacturer

Tyco Healthcare group LP
  • Source
    HPRA