H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of unit had one instance of the image flickering and then it locked up requiring a reboot.It also showed an ec114 low memory error was unconfirmed; the unit did not give an ec 114 error as the unit was being evaluated.The probe is also giving a bright and clear image.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.
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