Events

Alerte De Sécurité sur Respirator BiPAP AUTOSV ADVANCED SYSTEM ONE WITH HEATED TUBE, Hazard Class II, Registration 10216719019 (Series 60) /////// BiPAP AUTOSV ADVANCED SYSTEM, ONE (Series 50), Registration 10216719015,, Serial number 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
    1600
  • Date
    2015-06-03
  • 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
    The identified safety problem represents a significant increase in the risk of cardiovascular death in patients with symptomatic chronic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) who are being treated with Adaptive Servoventilation. There were no questions associated with the performance of the VSA therapy device in the study. #### UPDATED ON 07/18/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Cause
    During the preliminary analysis of primary data from the serve-hf clinical study, a serious safety concern was identified. this study investigated the effect of adaptive servo injection (vsa) therapy on hospitalization rates and mortality in patients with symptomatic chronic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef ≤ 45%) and central apnea moderate to severe predominant sleep (ahi ≥ 15 / h, cahi / ahi ≥ 50% and cai ≥ 10 / h).
  • Action
    According to the registry holder, up to the completion of the investigation, based on ResMed data, it is strongly recommended that clinicians follow recommendations that warn of the use of ASV therapy in patients with symptomatic chronic heart failure (NYHA 2 -4) and reduced LVEF ≤ 45%, and moderate to severe predominant central sleep apnea. Physicians who prescribe ASV therapy are advised not to place new patients in the at-risk population in the devices and to evaluate current patients. A discussion about continuity or otherwise of ASV therapy should be made if a current patient is considered within the at-risk population. Consequently, as a precaution, physicians should assess individual risks before prescribing therapy with the Philips devices listed above for the population of at-risk patients. No other patient population was identified as at risk for adverse outcomes.

Device

Respirator BiPAP AUTOSV ADVANCED SYSTEM ONE WITH HEATED TUBE, Hazard Class II, Registration 10216...

Manufacturer

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