Events

Alerte Ou Avis De Sécurité sur Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2

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 Philips Healthcare (Children’s Medical Ventures).

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/2014/043
  • Numéro de l'événement
    CON478816
  • Date
    2014-11-25
  • Date de publication de l'événement
    2014-11-25
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON478816?tabName=allTabs
  • 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
    Risk of infection, breathing difficulties and allergic reactions. philips healthcare (children’s medical ventures) is aware of mould growth on these neonatal and paediatric support devices. the mould has been identified as cladosporium and penicillium fungi. the manufacturer has issued a revised field safety notice (fsn) dated 10 october 2014.
  • Action
    Stop using all these devices, even if you can’t see any mould on them. Dispose of all the devices according to your local environmental guidelines. Fill in the customer reply form attached to the FSN and return it to your distributor. This MDA replaces MDA/2014/038 (issued 30 September 2014).

Device

Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    Neonatal and paediatric support devices. All batches of: Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2. These gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. The part number is printed on the product itself.
  • Manufacturer
    Philips Healthcare (Children’s Medical Ventures)

Manufacturer

Philips Healthcare (Children’s Medical Ventures)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    MHRA