Events

Alerta De Seguridad para Automatic CPAP device DREAMSTATION

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd.

¿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
  • ID del evento
    I1703-116
  • Número del evento
    2016DM-0014710
  • Fecha
    2017-03-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=95
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has identified that the medicoreferenced device experienced an erroneous configuration during its manufacture, which prevents the modem from making a satisfactory connection to the internet, a replacement of this modem is required to ensure a successful data transmission.

Device

Automatic CPAP device DREAMSTATION
  • Modelo / Serial
  • Descripción del producto
    The CPAP DREAMSTATION device is an automated system whose indication of use is to provide the patient with a positive depression therapy in the respiratory tract for the treatment of obstructive sleep apnea (OSA) in spontaneously breathing patients weighing more than 30 kg. It can be used both at home and in a hospital or health center. The DREAMSTATIONCPAP pro can also perform CPAP check therapy, and the DREAMSTATION AUTO CPAP can perform CPAP decompression therapy and AUTO CPAP therapy. The ramp function allows you to reduce the pressure when you are trying to stay calm. The air pressure will gradually increase until reaching the prescribed pressure. It comes with accessories and accessories for its total operation.
  • Manufacturer
    Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd

Manufacturer

Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc |...
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NIDFSINVIMA