The complaint allegation was not confirmed.The returned device was visually inspected, and no problems were noted with the device.The returned device was assembled with a new ar-6410 arthroscopy pump tubing and was tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and no error messages and no audible alarms were triggered.A clamp test was performed as defined in the user guide (dfu-0212 rev 1 ¿ section 5.2) to simulate an over pressure failure on the pump, and to verify if an error message and/or audible alarm would be triggered.The results of the clamp test indicate the pump triggered an alarm and the rollers stopped moving.This is expected behavior.When the pressure was artificially lowered by removing the inlet from the fluid source, an alarm was triggered, and the device stopped.This behavior is expected.The review of complaint records for serial number (b)(6) shows that the device has no previous complaints.
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