Аналіз інформації за період 01.05.2015 - 31.05.2015, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

https://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm

 

·                     21 May 2015 Reissue - Philips ventilators BiPAP autoSV, BiPAP autoSV Advanced, OmniLab Advanced, OmniLab Advanced + and HeartPAP devices

(Philips Healthcare) Philips recommend you check these devices for risks after an alert was issued about ResMed's ventilators with Adaptive ServoVentilation (ASV) mode.

Медичний виріб: вентилятор виробництва Philips Healthcare

 

·                     13 May 2015 Specific ResMed ventilators with Adaptive ServoVentilation (ASV) - increased risk of cardiovascular death in patients who have a specific heart condition

(ResMed Ltd) Physicians should assess all patients currently being treated with ASV mode for symptomatic chronic heart failure and if necessary undertake an assessment of LVEF.

Медичний виріб: вентилятор виробництва ResMed Ltd