Events

Safety Alert Or Field Safety Notices for ClinActiv and ClinActiv Plus Therapy Surface

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/2013/086
  • Event Number
    CON355521
  • Date
    2013-12-19
  • Event Date Posted
    2013-12-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON355521?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
    Silicone oil may leak out of the pressure sensor of the mattress and spill onto the floor. patients or carers may slip in the oil and injure themselves. the manufacturer has developed instructions on how to clean up these leaks but they were not included in the field safety notice dated 22 july 2013. in addition, the manufacturer has not received sufficient confirmation from users that they have received and acted upon this information. the mhra remains in discussion with hill-rom about its corrective actions and sensor replacements.
  • Action
    Ensure all staff are aware of the instructions on how to clean up any silicone oil leakage (see appendix). Ensure the sensors are: checked annually replaced at least every 3 years included in your maintenance programmes. Return the customer response form to Hill Rom.

Device

ClinActiv and ClinActiv Plus Therapy Surface
  • Model / Serial
  • Product Description
    Pressure reducing air mattresses: ClinActiv and ClinActiv Plus Therapy Surface. Manufactured by Hill-Rom. Models N02050, N02051, P02062, P02063, P02064 and P02065. All serial numbers are affected
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom