The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the returned device and the reported incident from an analysis of the customer provided picture, which shows cassette insertion/pressure offset error message on the d25 control unit.The error message complaint has been confirmed and the root cause has been associated with a component failure.Factors that could have contributed to this reported event include; use of inadequate force while inserting the cassette.The missing component complaint could not confirmed because the device was not returned for evaluation.A review of the device history record showed there were no indications to suggest the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures.A review of the manufacturing process showed steps in the assembly of the device.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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