BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM (USA); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770500 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Code Available (3191)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.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 device has not been returned to the manufacturer, at this time, for evaluation.
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Event Description
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Per clin spec and vat director, poor image quality.Unable to visualize the needle and complaining the image is gray and grainy.This is causing inaccuracy with placements which is costing the team additional money in product and causing the patients to have multiple sticks.
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Event Description
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Per clin spec and vat director, poor image quality.Unable to visualize the needle and complaining the image is gray and grainy.This is causing inaccuracy with placements which is costing the team additional money in product and causing the patients to have multiple sticks.
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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 device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality is unconfirmed.The scanner was evaluated and the image was found to be normal for a sr 8 scanner with the 32 mm probe.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, remanufactured and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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Search Alerts/Recalls
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