Medical device manufacturer: unknown.Device expiration date: unknown.Returned to manufacture on: unknown.The investigation date has been used in this field.(b)(6).Device manufacture date: unknown.Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for 72042 with the incident lot was observed.Although the cause of the malfunction was identified as a loose cable, the reason as to why the cable was loose could not be established.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.
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