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 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 ec111 error was confirmed.Although the error did not occur during the assessment, it was found in the logs that the ec111 error was displayed.The root cause is due to a general system error.The sr8 will be re-imaged to clear the error.H3 other text : evaluation findings are in section h.11.
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