BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, US; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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Event Description
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Company technical support engineer reported ultrasound image has a delay during scanning.
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Manufacturer Narrative
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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 reported issue was confirmed at bas by engineering.The log files were evaluated by engineering and was found to be caused by an intermittent software issue.However, the root cause of the reported image delay issues could not be determined.The equipment will remain at engineering for further testing.
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Event Description
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Company technical support engineer reported ultrasound image has a delay during scanning.
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Search Alerts/Recalls
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