Events

Safety Alert Or Field Safety Notices for Dynamis and Gerialit with Dewert electrical control systems

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom 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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/031
  • Event Number
    CON272240
  • Date
    2013-05-10
  • Event Date Posted
    2013-05-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON272240?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of serious injury to patients, staff and visitors. unintentional movement, including sudden collapse to its lowest position, can occur when the bed is connected to the mains supply. a field safety notice (fsn) was published on 01 march 2012.  however, the manufacturer has since advised that these beds should be fixed to their lowest position and the control system deactivated to remove the risk of injury.
  • Action
    Identify affected beds. Consider removing affected beds from use if alternatives are available. If an alternative is not available: consider whether continuing to use the beds at their fixed, lowest position is acceptable if acceptable, fix the beds to their lowest position and contact the manufacturer for instructions on how to deactivate the Dewert control system. Confirm with the manufacturer your actions when completed.

Device

Dynamis and Gerialit with Dewert electrical control systems
  • Model / Serial
  • Product Description
    Hospital beds: Dynamis and Gerialit with Dewert electrical control systems. Specific models numbers manufactured from October 1995 to June 2001 inclusive. Dynamis and Gérialit beds were manufactured with electrical control systems supplied by either Dewert or SKF. This notification applies only to Dewert systems, which are easily recognizable by the design of the lockout unit, as shown in the manufacturer’s Field Safety Notice, MOD 466. Affected model numbers: LI146B1—LI146BI, LI146D1—LI146DI, LI147B1—LI147D1, LI150A0—LI150B0, LI163B1—LI163C1, PRS0128, PRS0199, PRS0201, PRS2001.
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom