Events

Alerte De Sécurité sur Pulmonary Ventilator, models Trilogy 202 / Trilogy 100 / Trilogy 200, registration 10216710280 and 10216710291, risk class III, serial numbers affected (SEE ANNEX).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Philips Medical Systems Ltda.; Respironics, Inc..

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
    1808
  • Date
    2016-01-21
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Philips will shortly release the updated device software to avoid the problem described above. Updated device software will be available at my.respironics.com. Customers of this product will receive a letter stating the availability of the updated software. /// The registry holder has been reinforced by the need for users to verify the correct prescription for their therapy session, displayed in the upper left corner of the Trilogy screen.
  • Cause
    Philips respironics has learned that trilogy fans, with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01, are susceptible to an accidental change in prescriptions. this can occur under a certain set of operating conditions and after a specific sequence of keystrokes without requiring the user to confirm the change. the devices continue to display precisely the active prescription in the upper left corner of the screen. since this change in prescription was accidental and no confirmation was required, the user may not have noticed this change.
  • Action
    Field Correction by releasing the updated software from the device to avoid the problem described above. The updated device software will be available at my.respironics.com //// Recommendations to users and patients: 1. Complete and return the Business Response Form. 2. Affected devices may continue to be used in accordance with the Device Instructions for Use and this Safety Notice. 3. Notify users with affected devices of the following: - Check the correct prescription for your therapy session, displayed in the upper left corner of the Trilogy 4 screen. In accordance with your usual operating procedures and / or maintenance schedule, update the device software as it becomes available. (Field Action: FSNR-01-2016-A)

Device

Pulmonary Ventilator, models Trilogy 202 / Trilogy 100 / Trilogy 200, registration 10216710280 an...

Manufacturer

Philips Medical Systems Ltda.; Respironics, Inc.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA