Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Handicare AB 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 212 08 15 000
  • 사례 시작날짜
    2015-08-30
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=8165
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Transition gate manual is used to connect two rails in a ceiling lift system. typically it connects a single rail to a traverse system. the design of transition gate manual forces the safety pins in the gate to their upper, open, position when the rails are aligned and ensures that the safety pins are pushed back to their lower, closed, positions when the rails are pulled apart. if the safety pin is pushed repeatedly by one of the trolley types mentioned above, the wiggling of the trolley will cause a movement of the safety pin upwards . this can only occur if transition gate manual is used in combination with the types of trolleys specified above, and with a low load or non-load onto the lift. the friction between the bushing and the safety pin can hinder the pin from falling down by itself, leaving the rail open and allowing the trolley to pass and fall to the floor.

Device

Transition gate manual in combination with Reda ceiling lift unit or trolley HCS5 / HCS37
  • 모델명 / 제조번호(시리얼번호)
    Model: 50400226, 50400237, 50400238 See attached FSN
  • 제품 설명
    Stationary patient lifting system, line-powered
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB