C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
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 01/17/2024 |
Event Type
malfunction
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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 device has not been returned to the manufacturer for evaluation.
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Event Description
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Customer reports sr8 having snowy/grainy images issues.Verified they've tried adjusting the filters.Same issue.Verified they've swapped probes.Same issue.Will not scan past the 2cm mark.
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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 the service facility for evaluation.During evaluation, the reported issue of sr8 having snowy/grainy images issues was unconfirmed.The sr8 and cue probe were tested side by side with an internal sr8 and cue probe.The images are comparable, and no image issues were found.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.H3 other text : evaluation summary findings in h:11.
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Event Description
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Customer reports sr8 having snowy/grainy images issues.Verified they've tried adjusting the filters.Same issue.Verified they've swapped probes.Same issue.Will not scan past the 2cm mark.
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Search Alerts/Recalls
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