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 Apparent Adverse Event (3189); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
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.
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Event Description
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It was reported by a (b)(6): the sherlock us machine freezes during vein finding.It used to freeze/ stop for split second, but now the machine freezes even longer (probably as long as 3 to 5 secs).There has been several incidents where poked the skin and the machine freezes, so i have to look again for my needle tip and re-orient my sonogram.The 3-5 second pause may not seem long, but it is when you have a needle inside where we can¿t see how deep it is.No other information was provided.The exact number of occurrences was not provided by the complainant.
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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 system freezing was unconfirmed.The sr8 was further investigated and did not freeze during testing or after running overnight.Reported issue root cause: the reported issue could not be confirmed, therefore there is no root cause.
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Event Description
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It was reported by a nurse: the sherlock us machine freezes during vein finding.It used to freeze/ stop for split second, but now the machine freezes even longer (probably as long as 3 to 5 secs).There has been several incidents where poked the skin and the machine freezes, so i have to look again for my needle tip and re-orient my sonogram.The 3-5 second pause may not seem long, but it is when you have a needle inside where we can¿t see how deep it is.No other information was provided.The exact number of occurrences was not provided by the complainant.
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Search Alerts/Recalls
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