Oxylog Transport Ventilators 의 안전성 경고

Safety alert

2014-02-20

2014-02-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140220b.html

Medical device safety alert: draeger oxylog transport ventilators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning oxylog transport ventilators manufactured by draeger medical. the affected model numbers are oxylog 3000plus and oxylog 2000plus, and the affected serial numbers are asej-0138 and asek-0011. the manufacturer has received reports of devices displaying the error message “poti unplugged”. the investigation has revealed that a limited batch of faulty control panel pcbs - onto which the potentiometer for setting the ventilation parameters is soldered. this can result in the contact to the respective potentiometer being interrupted. the device then discontinues ventilation, gives an audible alarm and displays the error message poti unplugged. the manufacturer advises users that if this error occurs they must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the instructions for use manual. furthermore, the manufacturer will be contacting all affected users to organise the correction of the affected devices. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00168-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 february 2014.