Physio-Control LIFEPAK 15 Monitor/Defibrillator 의 안전성 경고

Safety alert

2017-02-10

2017-02-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170210.html

Medical device safety alert: physio-control lifepak 15 monitor/defibrillator the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 15 monitor/defibrillator, manufactured by physio-control, with manufacturing dates from 3 september 2014 to 30 june 2016 and distribution dates from 13 september 2014 to 4 july 2016. the manufacturer is recalling the lifepak 15 monitor/defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. if the electrical shock is not delivered, the monitor will indicate “abnormal energy delivery” on the display. a delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. for details, please refer to the following websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm540979.Htm http://www.Physio-control.Com/workarea/downloadasset.Aspx?id=2147498478 according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 february 2017.