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 evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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The following were reviewed as part of this investigation: patient severity, trend analysis, 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 reported issue of delayed ultrasound imaging was confirmed by the service facility and through video attached from the complainant.The site-rite 8 scanner was returned to the service facility for evaluation, however the root cause could not be determined.The service facility re-imaged the scanner as a precaution due to the delay in the image.The system was tested for functionality prior to returning equipment to customer.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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