The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of manufacturing records found the device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of mdu and footswitch port malfunctions could not be reproduced.Product passed functional testing with no faults or errors.Both mdu ports and the footswitch port perform as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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