Optima XL stubby handle 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Timesco of London 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2007/045
  • 사례 연번
    CON2031338
  • 날짜
    2007-06-04
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 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
  • 원인
    Poor contact between timesco stubby handles and timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation. timesco believe that there may be a possibility that the electrical contact on the stubby handle may become bent out of position when used with an early design of callisto disposable blade (pre november 2003), which depressed the bulb slightly more than the current timesco callisto single-use design and other timesco reuseable blades. this could have resulted in the bulb failing to be lit if the handle was subsequently used with any current timesco design blade. the stubby handle electrical contact is shown in figure 1 below. timesco sent a letter to inform customers of this issue in february 2007 and, as a precautionary measure, they implemented a redesigned contact mechanism in the stubby handle in january 2007 figure 1. stubby handle electrical contact.
  • 조치
    Identify all stubby handles that are currently in use. Regularly check that the contact spring is adequately elevated to make good contact with the laryngoscope bulb when the bulb is depressed. Check the function of the handles before each use.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd. Models: 3000.308.10 and 3000.308.10T. A Timesco stubby handle is a short length laryngoscope handle often used for difficult intubations. Callisto blades are also manufactured by Timesco. Instructions for use are supplied with each stubby handle.
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    MHRA