Events

Cook Vacuum Pump for IVF 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Cook Medical 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
    Safety alert / Field Safety Notice
  • 날짜
    2018-05-24
  • 사례 출판 날짜
    2018-05-24
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/cook-vacuum-pump-for-ivf-risk-of-electric-shock-or-burn-to-operator
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    The manufacturer identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0.The potential hazardous situations which could arise as a result of this include; failure of the device to operate or electric shock or burn to the user.
  • 원인
    Manufactured by cook medical – risk of electric shock or burn, and failure of the device to operate during ivf procedures because of non-compliant mains wiring.
  • 조치
    Identify the affected devices as stated in device details and, in the manufacturer’s, Field Safety Notice (FSN). Ensure that all users receive the manufacturer’s FSN and that they understand the problem. Ensure a residual current device (RCD), which is marked stating its compliance with BS 7071, is fitted to the mains electricity supply to mitigate the risk of a hazardous situation. RCDs are also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI). If you do not have access to an RCD (or equivalent) do not use the vacuum pump until the mains wiring for the unit has been replaced by the manufacturer. If an adverse event occurs relating to this issue please report this to the MHRA via Yellow Card or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

Cook Vacuum Pump for IVF
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Product Name Reference Part Number Global Product Number Lot Numbers Cook Vacuum Pump™ K-MAR-5200 G49275 All lots
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical
  • 제조사 주소
    Cook Medical Ms. Sinead BurkeTel: +353 (0)61 334440Sinead.burke@CookMedical.com
  • 제조사 모회사 (2017)
    Cook Group Incorporated
  • Source
    MHRA