Customer is reporting that they believe the chamber is not functioning properly as there have been patient issues while in the chamber.A patient injury, chest tightness, was reported.After the chamber was evaluated by trained sechrist technician, it was determined that the chamber was functioning as intended and within its specifications.The customer complaint could not be confirmed.Therefore, the patient injury was not a result of the chamber not functioning properly.There is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe use of the device.Therefore, no corrective or preventive actions are necessary at this time.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file no.:(b)(4).
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