Field Safety Notices about Völker ™ Beds 2080, 2082, S 280, S 282

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 MODS.

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
  • Event Source
  • 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
    Our records show that your business has purchased one or more of the beds mentioned above.   hill-rom has received notice that the side rails on the völker ™ 2080 bed accidentally and suddenly drop when the patient leans over the side rail with full body weight. we evaluated the potential risk and determined the possibility of occurrence of less than 9 / 100,000 units or 0.009%. hill-rom wants to remind users of the völker ™ 2080, 2082, s 280 and s 282 bed rails with lateral release buttons for proper use of the side rails. if the patient needs to get out of bed, ensure that the side rails are fully lowered and that they do not directly load the full weight of the body.