Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter Kits 의 안전성 경고

Safety alert

2014-04-16

2014-04-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140416.html

Medical device safety alert: fisher & paykel infant nasal continuous positive airway pressure (cpap) prongs and bubble cpap starter kits the australia therapeutic goods administration (tga) posted a medical device safety alert concerning infant nasal continuous positive airway pressure (cpap) prongs and bubble cpap starter kits, manufactured by fisher & paykel healthcare ltd.(fph) the manufacturer has received customer reports relating to certain lot numbers of certain models of nasal cpap prongs detaching from the fph flexitrunk nasal tubing, especially in the presence of mucous and/or moisture. in the event of the affected prongs detaching from the nasal tubing, therapy is likely to be interrupted. this may lead to a patient becoming hypoxic. the manufacturer requests customers to identify any units form the affected lot and destroy the affected prong. for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00437-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2014.