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 the information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of unit shuts down mid-procedure was unconfirmed.The unit was charged to 100% then let discharge to 0%.It took 2 hours and 30 min to discharge to 0% which means the unit is working properly.There is no root cause as the issue could not be duplicated h3 other text : evaluation findings are in section h11.
|