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 Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/27/2023 |
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 device has not been received by the manufacturer for evaluation.H3 other text : device not returned.
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Event Description
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It was reported the customer's probe is having issues with the images dropping out.
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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 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 the information, the following was concluded: the device was returned to service facility for evaluation.During evaluation, the reported issue of the image is dropping out was confirmed.The probe has a dark spot in the middle of the image.The root cause is due to an internal failure.
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Event Description
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It was reported the customer's probe is having issues with the images dropping out.
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Search Alerts/Recalls
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