The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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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, the reported issue of a dark ultrasound image could not be reproduced.The scanner was evaluated and the image was found to be normal for a sr 8 scanner with the 32 mm probe.There were no issues identified with the equipment.Manufacturing records were reviewed and there were no events that could have contributed to the reported complaint.The sr8 was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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