C.R. BARD, INC. (BASD) -3006260740 SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problems
Poor Quality Image (1408); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Event Description
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It was reported by customer that ultrasound probe went dead.12/26/2023 - additional details: probe is producing a black image.Started out with a black line down screen at first.
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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 received by the manufacturer for evaluation.H3 other text : device not returned.
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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 black screen/poor image quality was confirmed.There is no image produced.The root cause of the failure was identified as an internal failure of the probe.
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Event Description
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It was reported by customer that ultrasound probe went dead.12/26/2023 - additional details: probe is producing a black image.Started out with a black line down screen at first.
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Search Alerts/Recalls
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