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: during evaluation for a different reported issue (see related complaint), the probe was found to cause interference in the bottom of the ultrasound image, an ec204 error is produced when calibrating the gt function, and the probe button functionality is intermittent.The root cause of the probe failures was identified as an internal failure in the probe.The device was serviced, tested, and returned to the customer 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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