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
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 09/18/2023 |
Event Type
malfunction
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Event Description
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It was reported the screen intermittently going black.Windows activation icon pops up on screen.Ecg icon disappears intermittently.
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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.
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Event Description
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It was reported the screen intermittently going black.Windows activation icon pops up on screen.Ecg icon disappears intermittently.
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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 screen is going black intermittently was unconfirmed.The unit is functioning properly.The screen is not going intermittently black.There is no root cause as the issue could not be reproduced.
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