[179705876]
The manufacturer became aware of an allegation of a thermal event occurring to the dc power supply and the dc power input of the continuous positive airway pressure (cpap) device. There was no patient harm or injury. The manufacturer received the cpap and associated humidifier for investigation. There was evidence of thermal damage to the dc output connector on the power supply and the dc power input connector of the cpap due to water ingress to the device which caused rust and corrosion to the power connectors. The finding of water ingress to the dreamstation assembly indicates the units were moved or mishandled while there was still water in the chamber or from water being spilled when filling the chamber and the devices setting in this water. The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over (b)(6). It is for use in the home or hospital/institutional environment. The user is cautioned "contact your health care professional if symptoms of sleep apnea recur. If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use. Contact your home care provider. " the power supply is designed in accordance to iec 60601 and applicable parts of iec 60950. Voltage in the cpap/humidifier device is limited to 12 v dc nominal, and current is limited by the device fuse, to minimize the potential for electrical fire. The design of the electronics mechanicals are robust enough to resist damage that would result from typical usage. This device meets ul and iec requirements for flammability. There was no patient harm or injury. The manufacturer concludes that no further action is necessary at this time.
Patient Sequence No: 1, Text Type: D, B5