Events

Safety Alert for Ventilation support system BIPAP, Bipap Auto SV, registration 80102510425, risk class II, all batches.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora de Produtos Médicos; Respironics Inc. (Currently Philips Respironics).

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1646
  • Date
    2015-07-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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
  • Reason
    Resmed has issued an urgent safety notice describing an absolute greater annual risk of a statistically significant 2.5 percent cardiovascular mortality rate for individuals randomized to resmed assisted ventilation (asv) therapy compared to the control group. in the population of patients with reduced left ventricular ejection fraction (lvef ≤ 45%), 10% of the asv group suffered vascular death per year compared to 7.5% of the control group, representing a higher risk of cardiovascular mortality (hr = 1.335, 95% ci - (1.070, 1.666), p value = 0.010).
  • Action
    The registry holder recommends not placing new patients with symptomatic CHF (NYHA 2-4) and LVEF ≤45% and predominantly moderate to severe central sleep apnea in ASV therapy. Before using therapy, each patient should be evaluated for Heart Failure. In the case of signs and symptoms for this disease, an objective evaluation of LVEF should be performed. Current patients should also be evaluated and a discussion of whether or not therapy should be continued should be considered within the at-risk population.

Device

Ventilation support system BIPAP, Bipap Auto SV, registration 80102510425, risk class II, all bat...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos; Respironics Inc. (Currently Philips R...
  • Source
    ANVSANVISA