Events

Alerta De Seguridad O Notificaciones De Seguridad para Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Philips Healthcare (Children’s Medical Ventures).

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2014/043
  • Número del evento
    CON478816
  • Fecha
    2014-11-25
  • Fecha de publicación del evento
    2014-11-25
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON478816?tabName=allTabs
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    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)
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    MHRA