C.R. BARD, INC. (BASD) -3006260740 BD SITERITE 9 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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Event Description
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It was reported by a tm - the probe calibration is saying 3 leads are failing.Then where the probe lead are affected are not delivering a picture on the edges.
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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.Product was not returned for evaluation/repair.Photo sample provided shows multiple transducer elements have failed.However, complaint investigation and root cause determination could not be completed without physical evaluation of the unit.H3 other text : evaluation summary findings in h:11.
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Event Description
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It was reported by a tm - the probe calibration is saying 3 leads are failing.Then where the probe lead are affected are not delivering a picture on the edges.
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Search Alerts/Recalls
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