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Catalog Number 9770066 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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 device has not been returned to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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Event Description
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Nurse and sales rep reported system has grainy image, possible a result of the system losing the context vision license key.
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Manufacturer Narrative
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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: the device was returned to the service facility for evaluation.During evaluation, the reported issue of system has grainy image was confirmed.The scanner boots to a context vision key entry screen due to an internal failure in the compact flash card.This results in poor image quality.The device was serviced, tested, and returned to customer.The device has not been returned to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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Event Description
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Nurse and sales rep reported system has grainy image, possible a result of the system losing the context vision license key.
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Search Alerts/Recalls
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