Alerta De Seguridad para Oxylog Transport Ventilators

Safety alert

2015-12-28

2015-12-28

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151228b.html

Medical device safety alert: draeger oxylog transport ventilators medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning oxylog transport ventilators manufactured by draeger medical. the affected model numbers are oxylog 2000plus, oxylog 3000 and oxylog 3000plus. the manufacturer has become aware of situations where the error message “poti unplugged" was generated. in those cases, an audible and visual alarm is generated, the breathing system releases pressure and the ventilation function stops operating. according to the manufacturer, no patient injury has been reported due to the issue. the error message is caused by increased electrical contact resistances of the controllers (adjustment potentiometers) that are caused by an oxide layer on the controllers, which accumulates over a longer period of time if the controllers are moved rarely or never. the manufacturer’s product monitoring has shown that some users rarely use the fio2 controller or do not use it at all. as a preventive measure, the manufacturer highly recommends to move all controllers once when the affected device is switched off; at least 10 times to the left and right stop (minimum and maximum value). this measure suffices to clean the resistance taper of the controllers sufficiently. in particular with the error “device malfunction – poti unplugged”, the aforementioned method can also be used to put the device back into operation. the manufacturer reminds users that the affected devices must only be used after verifying its operational readiness. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the following link:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01256-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 december 2015.