Events

Alerte De Sécurité sur Automatic CPAP device DREAMSTATION

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Respironics Respiratory Drug Delivery (Uk) Ltd || Respironics Inc || Respironics California Inc || Respironics Medical Products (Shenzhen) Co, Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1703-116
  • Numéro de l'événement
    2016DM-0014710
  • Date
    2017-03-30
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=95
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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 |...
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NIDFSINVIMA