C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problems
No Display/Image (1183); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2023 |
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 the screen is intermittently going blank in the middle of using.Staff says that lights are still illuminated on the bezel and the battery has been changed with no resolution of this error.
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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 this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of screen is intermittently going blank is unconfirmed.The unit was tested for functionality and functioned properly without the screen going blank.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported the screen is intermittently going blank in the middle of using.Staff says that lights are still illuminated on the bezel and the battery has been changed with no resolution of this error.
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Search Alerts/Recalls
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