Events

Universal SlingBar 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 Hill-Rom 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
  • 사례 국가
    Slovenia
  • 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
    Hill-rom has become aware of a potential safety issue related to the universal slingbar 350, slingbar 450 and slingbar 600 which could be attached to various liko overhead and mobile patient lifts. complaints have been received that the center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. the potentially affected sling bars have been produced until may 2014. analysis has shown that the sling bar is reliable when used as intended with the sling bar level during the lift. however, if the sling bar is not used as intended, the bolt may be weakened. if the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. this hazard could cause potentially minor to catastrophic injuries to a patient. .

Device

Universal SlingBar
  • 모델명 / 제조번호(시리얼번호)
    Universal SlingBar 350, p/n 3156074, 3156084 and 3156094 Universal SlingBar 450, p/n 3156075, 3156085 and 3156095 Universal SlingBar 600, p/n, 3156076 and 3156086 These may be bundled with the Golvo™, Uno™, LikoLight™, Likorall™, Multirall™ and Viking™ XS/S/M/L mobile patient lifts.
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom