Events

Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and Masterlift® Systems 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
    Corrosion on ceiling mounted overhead lift rail system installations in indoor swimming pool areas this field safety notice relates to fasteners securing overhead lift rail systems to ceilings in highly chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. to date, this has been reported to hill-rom twice with over 85,000 installations worldwide. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the hardware. scc is a type of localized corrosion characterized by fine cracks which can propagate rapidly leading to failure of the components. scc may occur in the presence of highly chlorinated environments such as swimming pool areas. there is a small risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders. .

Device

Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and M...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom