Alerta De Seguridad para Heated Ventilator and CPAP Breathing Circuits

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Armstrong Medical Limited.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: armstrong medical heated ventilator and cpap breathing circuits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning heated ventilator and cpap breathing circuits, manufactured by armstrong medical limited. the affected devices could be identified by the following information: catalogue no.: amcp- or amho- or amvc17- or amvc18-. lot no.: 080310 to 310812 (ddmmyy) or expiry date in the range 2015-02 to 2017-07 the manufacturer is investigating a component used in its heated ventilator and cpap breathing circuits manufactured using corrugated tubing. this notice does not apply to any armstrong medical heated breathing circuit manufactured using smooth bore tubing. the component is referred to as a heater wire retainer and is located in the heated limbs of adult (22mmo) corrugated heated ventilator and cpap breathing circuits as a means to locate the heater wire in a fixed position. the retainer is white or off-white in colour and made from polymeric (plastics) material. if breakage of this component were to occur there could be a possible inhalation risk to the patient. as a voluntary, precautionary measure and in advance of full details of an incident being made available, the manufacturer has decided to recall potentially affected breathing circuits and replace these with circuits which use an alternative form of retainer made from metal. as a precaution until affected stock can be replaced, users are advised to confirm the absence of loose fragments of heater wire retainer inside the heated limb(s), referring to figure 1 of the field safety notice for guidance. for details, please refer to the mhra website as below: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185586 if you are in possession of the products, please contact your supplier for information and necessary actions. posted on 4 october 2012.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Armstrong Medical Heated Ventilator and CPAP Breathing Circuits
  • Manufacturer