Heated Ventilator and CPAP Breathing Circuits 의 안전성 경고

Safety alert

2012-10-04

2012-10-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121004.html

Medical device safety alert: armstrong medical heated ventilator and cpap breathing circuits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning heated ventilator and cpap breathing circuits, manufactured by armstrong medical limited. the affected devices could be identified by the following information: catalogue no.: amcp- or amho- or amvc17- or amvc18-. lot no.: 080310 to 310812 (ddmmyy) or expiry date in the range 2015-02 to 2017-07 the manufacturer is investigating a component used in its heated ventilator and cpap breathing circuits manufactured using corrugated tubing. this notice does not apply to any armstrong medical heated breathing circuit manufactured using smooth bore tubing. the component is referred to as a heater wire retainer and is located in the heated limbs of adult (22mmo) corrugated heated ventilator and cpap breathing circuits as a means to locate the heater wire in a fixed position. the retainer is white or off-white in colour and made from polymeric (plastics) material. if breakage of this component were to occur there could be a possible inhalation risk to the patient. as a voluntary, precautionary measure and in advance of full details of an incident being made available, the manufacturer has decided to recall potentially affected breathing circuits and replace these with circuits which use an alternative form of retainer made from metal. as a precaution until affected stock can be replaced, users are advised to confirm the absence of loose fragments of heater wire retainer inside the heated limb(s), referring to figure 1 of the field safety notice for guidance. for details, please refer to the mhra website as below: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185586 if you are in possession of the products, please contact your supplier for information and necessary actions. posted on 4 october 2012.