C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Catalog Number 9770600 |
Device Problems
Poor Quality Image (1408); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Event Description
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It was reported that the image quality is degrading and is coming out grainy and pixelated.Verified they swapped probes and that doesn't appear to resolve their issue.Also verified they have tried adjusting the settings.No other information provided, at this time.
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Manufacturer Narrative
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H11: section a through f - 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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
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Event Description
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It was reported that the image quality is degrading and is coming out grainy and pixelated.Verified they swapped probes and that doesn't appear to resolve their issue.Also verified they have tried adjusting the settings.No other information provided, at this time.
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Manufacturer Narrative
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H11: section a through f - 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 device was returned to service facility for evaluation.During evaluation, the reported issue of the images are grainy was unconfirmed.The images are within the specifications of the unit.There is no root cause as the issue could not be reproduced.H3 other text : evaluation summary findings in h:11.
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Search Alerts/Recalls
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