Events

Safety Alert for Flow Generator with Heated Humidifier and Accessories, VPAP Tx and VPAP Adapt SV Models, Registration - 80047300518, Serial Numbers - Annex 1 and 2. //// VPAP ADAPT SV, VPAP ADAPT SV and S9 VPAP ADAPT models Brazil - 36097, registration 80047300198, risk class III.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; RESMED LTD.

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
    1598
  • Date
    2015-05-29
  • 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.
  • Reason
    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
    The company advises physicians who accompany patients with symptomatic chronic heart failure with reduced ejection fraction who are using ResMed VSA devices to contact these patients to discuss discontinuation of treatment. Further information in Annexes 3, 4 and 5.

Device

Flow Generator with Heated Humidifier and Accessories, VPAP Tx and VPAP Adapt SV Models, Registra...

Manufacturer

MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA.; RESMED LTD
  • Source
    ANVSANVISA