Device released from quality assurance to stock on 07/31/2019.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.During investigation the device history record (dhr) was reviewed.No issues were discovered, device passed all tests.Our investigation was limited to only the dhr review, the device was not returned for evaluation.Several attempts to obtain the device were made.The root cause could not be determined for this case.We will continue monitoring customer complaints for trends, which may require further investigation.
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Cardinal health customer service line was contacted by nurse (b)(6) on tuesday (b)(6) 2020.She stated that the device was reportedly not providing suction.Reported she had gone through all the troubleshooting steps, however, was not able to solve the issue.The device was reportedly not alarming, however, there was allegedly pooling of fluid in the wound site.The customer proceeded to contact her distributor for a replacement.
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