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Catalog Number 9770555 |
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, at this time, 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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Sales rep reported that image quality is poor, noting 'the veins are barely visible, vein can only be identified by compressing the probe into the skin.'.
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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 reported that image quality is poor was unconfirmed, as the reported issue could not be reproduced during evaluation.The scanner was evaluated with the model 550 phantom (b)(4) and the image was found to be normal for a sr 8 scanner with the 32 mm probe.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to customer.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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Sales rep reported that image quality is poor, noting 'the veins are barely visible, vein can only be identified by compressing the probe into the skin.'.
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Search Alerts/Recalls
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