Events

Alerta De Seguridad para practix33plus

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

¿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
    2012-10-03
  • Fecha de publicación del evento
    2012-10-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121003b.html
  • 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: philips practix33plus the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning practix33plus, manufactured by philips medical systems. from recent evaluations, the manufacturer have identified a potential issue in practix33plus that the welding seam of the tube support arm assembly might be imperfect, leading to a potential risk for a collapsing support arm. there is a potential for a serious injury of persons in case the support arm falls down on a patient's body. the manufacturer requested the customer to check the system for the safety flange. when there is no "safety flange" installed, the device is potentially at risk. when this flange exists the product is safe. in case there is no flange installed, the welding seams of the arm should be thoroughly checked for possible cracks by an experienced technician. in case of any cracks, immediately stop further operation of the system. philips will install the safety flange at all systems involved. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185586 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 3 october 2012.

Device

practix33plus
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Practix33plus
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH