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 touchscreen is unresponsive was confirmed.The scanner was inspected the touchscreen is unresponsive, the cause of the issue is due to a front enclosure failure, leading the scanner to be unresponsive to user input.The device was serviced, tested and returned to the customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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