The referenced device was not returned to the manufacturer; therefore, the exact cause of the reported event cannot be confirmed.As part of our investigation, multiple follow ups were made to the user facility to obtain additional information regarding the reported event but no information was obtained.However, based on the reported information, improper maintenance cannot be ruled out as a contributory factor to the reported event.Manufacturing and quality control review was performed for the 24 months due to missing lot numbers without showing any non-conformities or deviations regarding the described issue.If additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
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