Events

Alerta De Seguridad O Notificaciones De Seguridad para Legendair and Supportair Portable Ventilators

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 Airox.

¿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/2012/044
  • Número del evento
    CON172306
  • Fecha
    2012-07-12
  • Fecha de publicación del evento
    2012-07-12
  • 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/CON172306?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
    Potential for the ventilator’s internal battery to fail. this can result in non-ventilation of the patient. this is due to failure of a capacitor (c53) on the printed circuit board (pcb). the ventilator will still function on external battery power and mains power. the manufacturer published a revised field safety notice (fsn) (see appendix) in july 2012 to revise the action required. the manufacturer did not receive confirmation from users that they had received and acted upon the information in the first fsn published in april 2012.
  • Acción
    Locate and identify all affected ventilators. For ventilator dependent patients, contact the manufacturer for a replacement PCB and fit this as soon as possible, as per the FSN (see appendix). For non-ventilator dependent patients, contact the manufacturer for a replacement PCB (or C53 capacitor, if PCB is unavailable) which should be fitted no later than the next scheduled service, as per the FSN. In the interim, users should ensure that affected ventilators are kept on mains power, or if required for transport, that an external battery is used and a back up ventilator is available. Inform Covidien when the PCB or capacitor has been replaced for all your affected units. Be aware that the PCB or capacitor should be replaced on an annual basis as part of the revised annual preventative maintenance schedule. Ensure procedures are revised, if applicable.

Device

Legendair and Supportair Portable Ventilators
  • Modelo / Serial
  • Descripción del producto
    Legendair and Supportair Portable Ventilators. Specific ventilator codes (see FSN). Supplied by Airox and Covidien. These ventilators are designed primarily for use by patients at home. The affected ventilator codes are as follows: Legendair™ Single Branch 4095700 - INTL LEGENDAIR SINGLE BRANCH 4095701 - GB NO LEGENDAIR SINGLE BRANCH 4095702 - DE LEGENDAIR SINGLE BRANCH 4095705 - CA LEGENDAIR SINGLE BRANCH 4095706 - JP LEGENDAIR SINGLE BRANCH 4095709 - DK LEGENDAIR SINGLE BRANCH 4095721 - AU LEGENDAIR SINGLE BRANCH Legendair™ Double Branch 4095900 - INTL LEGENDAIR DOUBLE BRANCH 4095901 - GB NO LEGENDAIR DOUBLE BRANCH 4095902 - DE LEGENDAIR DOUBLE BRANCH 4095905 - CA LEGENDAIR DOUBLE BRANCH 4095906 - JP LEGENDAIR DOUBLE BRANCH 4095909 - DK LEGENDAIR DOUBLE BRANCH 4095921 - AU LEGENDAIR DOUBLE BRANCH Supportair™ 4096200 - INTL SUPPORTAIR 4096201 - GB SUPPORTAIR 4096202 - DE SUPPORTAIR
  • Manufacturer
    Airox

Manufacturer

Airox
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA