The esu were thoroughly inspected/tested.The esu was found to be functioning as intended.The evaluation included an electrical safety check, a functional check of each of the equipment's features and a power output check.The generator was/is within specifications and all features were/are functioning properly.Finally, no anomalies were found in the device history record (dhr) of the involved esu.In conclusion, no equipment problem was found that would have caused or contributed to the event.Most likely, there were many factors involved in the reported incident.However, the patient's disease state was most likely an important factor involved with the event.Nevertheless, no definitive determination as to what caused the incident could be ascertained.No trends have been identified and erbe usa, inc.Is now closing the file on this event.
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