Events

Alerte Ou Avis De Sécurité sur Hill-Rom TotalCare Duo 2

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par manufacturer #17429.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2007/065
  • Numéro de l'événement
    CON2032088
  • Date
    2007-07-22
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032088
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Hospital beds: Hill-Rom TotalCare Duo 2.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429