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 의 안전성 경고

Safety alert

1600

2015-06-03

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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).

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.