H3, h6, h10: 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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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.A complaint history review concluded this was a repeat issue.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, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Product evaluation performed by a s&n service center found a defective suction valve.The complaint was confirmed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Factors that could have contributed to the reported event include attempts to disassemble the suction valve for cleaning or an impact event inconsistent with normal use.
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