VENTilogic LS ventilators 의 안전성 경고

Safety alert

2014-01-14

2014-01-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140114.html

Medical device safety alert: weinmann medical technology ventilogic ls ventilators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ventilogic ls ventilators, manufactured by weinmann medical technology. details of the affected products are as follows: item numbers: 27130, 27700, 27710, 27750, 27940, 27950, 27951, 27960, 27970 powerboards: wm39890 index a and index b in extremely rare cases, a diode has failed due to an overload resulting from a voltage surge on the power board. this led to the ventilator failing, meaning that the patient's respiratory support was no longer guaranteed. the manufacturer has modified the layout and components of the affected power board to eliminate the possibility of future occurrence of this fault. devices which are currently in use for life-support ventilation among critical patients have priority and will be corrected by the manufacturer as quickly as possible. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con362312 if you are in possession of the product, please contact your supplier for necessary actions. posted on 14 january 2014.