Events

Field Safety Notices about Universal SlingBar

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Hill-Rom.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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