Age at time of event: the patient's exact age was not reported; however, the patient was reported to be in their 80s.This mdr refers to the first machine.A second mdr will be submitted to the fda for the second machine.Should additional relevant information become available, a supplemental report will be submitted.
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Correction: cfn/fei# 3003504604.H10: the device was not received for evaluation, however seven (7) photographs and two (2) videos were provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A device history review revealed no issues that could have caused or contributed to the reported issue.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The reported condition was not verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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