Evaluation of the returned device found the fio2 knob would not turn and the gas concentration output is at (b)(4)% o2.The balance regulator readings are all out of specification.Both the top and bottom set screws and the fio2 knob are loose.The loose components allowed the fio2 knob to slip on the shaft causing the knob to become stuck and the readings to be out of specification.Review of dhr 3500cp-g mixer sn (b)(4) (manufactured 09/05/2019) found no indication that there were any relevant discrepancies during manufacture of the device and no non-conformance that could have caused or contributed to the reported issue.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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.Mixers are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair, and as part of standard care the mixer should be inspected prior to use.If damage or functional issues are noted during these routine mixer inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing.Manufacturer reference file #(b)(4).
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