The device was returned to resmed and an evaluation confirmed the complaint.Visual inspection of the pneumatic block revealed contamination.The pneumatic block was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to contamination of the device pneumatic block.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
|