The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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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 ultrasound has streaks on the image as if a crystal is out was confirmed.The image has several dark streaks and the buttons do not function, the cause is an internal failure in the probe leading to poor quality on the image.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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