It was reported that this device stopped working.On return of the device for evaluation it was observed that the strain relief on the mains cord was not sitting in its recess, and the insulation on the mains cord was damaged to the extent that bare copper wires were exposed.Based on this, the patient may have been exposed to the risk of electrocution.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.' (b)(4).
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