Events

lifting systems with crane units 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Hill Rom Inc. || Liko Ab 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1605-214
  • 사례 연번
    2015DM-0013852
  • 날짜
    2016-05-18
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has identified a possible safety problem due to the failure of the central screw of the sling bar that connects the bar with the crane, the disadvantage is when the medical device is used inadequately, weakening the screw, there is the possibility that it breaks and the patient fall, which could lead to potentially adverse events on patients and / or users.

Device

lifting systems with crane units
  • 모델명 / 제조번호(시리얼번호)
    Golvo / UNO / Viking - SlingBar 350, SlingBar 450 and SlingBar 600
  • 제품 설명
    GOLVO: is a versatile crane, designed for use in most lifting situations. LIKORALL: it is a roof motor, it is designed and developed for the complete range of fixed or self-stable lifting systems of LIKO.MULTIRALL 200: it is a flexible roof crane with a versatile range of applications. It moves easily without compromising security and functionality. It is used to transfer from room to room. ROLLON: stand-up standing equipment, which has been developed to carry out safe transfers from and to the position of the seated patient. It is designed for patients with great difficulty in walking and good strength in the arms and ability to carry their weight on the legs. SABINA 200 designed for people with difficulty to stand up for simismas from a sitting position. SABINA II: designed for people with difficulty standing on their own from a sitting position. UNO 102: is a mobile crane with electric raising and lowering of the lift arm. Its use is in post-acute care centers such as nursing homes and other assistance centers. VIKING XS / S / M / L / XL: are two models of flexible mobile cranes that are excellent for small space environments. They are used for common elevationsFREESPAN SR: autonomous lifting system designed for use together with MULTIRALL crane units.
  • Manufacturer
    Hill Rom Inc. || Liko Ab

Manufacturer

Hill Rom Inc. || Liko Ab