Liko® Viking® L, Viking® M, Viking® XL, and Viking® 300 Mobile Lifts 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 MODS 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.
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 received 9 complaints where it is alleged that the lift arm drifted down suddenly on certain viking® mobile lifts. this issue is preceded by users who lift the lift arm assembly manually, as shown in the illustration to the right. the lift arm assembly is intended to only be lifted by the actuator (lift motor). if the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. when the actuator is stuck, the lift cannot be raised/lowered by the lift motor. if a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient. this hazard could cause minor or potentially catastrophic injuries to a patient if the free fall encompasses the entire stroke of the actuator. .