It was reported that this device was getting warm and smoking.On return of the device for evaluation, no heat damage was observed inside or outside the device.However, it was observed that the mains cable was damaged to the extent that bare wires were visible, potentially exposing the patient to the risk of electrocution.No information has been provided as to how the mains cord came to be in this condition.The ifu for this device contains the warning 'the power supply cord cannot be replaced by the user.In case the power supply cord becomes damaged, contact philips respironics customer service for replacement (there is no service option)'.No patient harm or death has been reported and the device is not life sustaining/supporting.Internal reference ra (b)(4).
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