Events

Safety Alert Or Field Safety Notices for Hill-Rom TotalCare Duo 2

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 manufacturer #17429.

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/2007/065
  • Event Number
    CON2032088
  • Date
    2007-07-22
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032088
  • 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
    The manufacturer has omitted to provide suitable decontamination instructions with this pressure relieving hospital bed. the mhra has received two reports of damaged mattress covers that allowed body fluids to soak into the mattress. no instruction was provided on how to check the condition of the mattress and cover. this presents a risk of cross infection. the manufacturer has omitted to provide customers with information on how to undertake suitable checks and decontamination procedures. the manufacturer does not include full decontamination details with the instructions for use, due to different requirements in different countries. in the uk they are covered in a separate document, w13001uks rev2. two nhs trusts have reported a risk of cross infection with this bed. residues of body fluids from previous occupants have been found under mattress covers. many of these beds are used by intensive care units. the mhra has not received any adverse incident reports of cross infection occurring due to this problem.
  • Action
    Trace all Hill-Rom TotalCare Duo 2 beds in use and in storage. Contact Hill-Rom on 01530 562167 for copies of the cleaning and disinfection instructions. Unzip the mattress covers and check for signs of fluid contamination on the mattress and damage or holes in the mattress covers. Dispose of damaged covers. If replacement or spare mattresses and mattress covers are required, contact Hill-Rom on 01530 411000 Between each patient use check whether any fluids have penetrated the cover and follow Hill-Rom’s cleaning, disinfection and laundry advice for the covers and mattresses.

Device

Hill-Rom TotalCare Duo 2
  • Model / Serial
  • Product Description
    Hospital beds: Hill-Rom TotalCare Duo 2.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429