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Model Number 9770501 |
Device Problems
No Display/Image (1183); 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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Sales rep reported since updating the software on the sr8, the system has been freezing and erasing saved files.
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Event Description
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Sales rep reported since updating the software on the sr8, the system has been freezing and erasing saved files.
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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 since updating the software on the sr8, the system has been freezing and erasing saved files was unconfirmed.The scanner was evaluated and no issues with the unit freezing or erasing saved files was noted.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, 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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