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Catalog Number 9770090R |
Device Problem
Device Stops Intermittently (1599)
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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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Sr prevue ultrasound system was reported to shut down while in use, without command.
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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 shuts down while in use, without command was unconfirmed.The device was serviced, tested, and discarded.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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Sr prevue ultrasound system was reported to shut down while in use, without command.
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Search Alerts/Recalls
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