Laerdal Suction Unit 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Laerdal 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
    Field Safety Notice
  • 날짜
    2016-09-27
  • 사례 국가
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    In order to ensure that your laerdal suction unit (lsu) is in compliance with iso 10079-11, one of the following actions described as option 1 and option 2 below must be taken. please read the below information carefully and report back to laerdal on the attached customer response form within three weeks. option 1: where the lsu is not stored or installed in cold temperatures - re-label the lsu with revised conditions at which the lsu can be stored and installed before operation if this is the case, you may continue to use the lsu without any changes to the unit. in order to inform end-users of the lsu about the limitation in operating conditions, we ask you to re-label your lsu with the revised operating conditions 12 °c to 40 °c (54 °f to 104 °f). to re-label your lsu, a new operating conditions label provided by laerdal medical is required. when labelled according to these instructions, the lsu complies with iso 10079-1 without need of any further actions. if you decide to re-label your lsu with revised operating conditions – please complete section 1 of the customer response form. in the response form, we ask you to specify the number of lsu units that are currently in use, so that laerdal medical may provide you with a suitable number of labels. .

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