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Model Number 9770500 |
Device Problems
Loss of Power (1475); Battery Problem (2885)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number dyasac016 showed no other similar product complaint(s) from this serial number.
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Event Description
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Per rn: the machine shuts down after being plugged in all night around 86% battery life.This is very inconvenient to have the machine turn off in the middle of a procedure.
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Event Description
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Per rn: the machine shuts down after being plugged in all night around 86% battery life.This is very inconvenient to have the machine turn off in the middle of a procedure.
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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 system shutdown abruptly was confirmed.The scanner will shut down after a few minutes unplugged from the power supply.The root cause of the failure was identified as an internal failure in the lithium ion battery.The device was serviced, tested, and returned to the customer.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number dyasac016 showed no other similar product complaint(s) from this serial number.
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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 system shutdown abruptly was confirmed.The scanner will shut down after a few minutes unplugged from the power supply.The root cause of the failure was identified as an internal failure in the lithium ion battery.The device was serviced, tested, and returned to the customer.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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Event Description
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Per rn: the machine shuts down after being plugged in all night around 86% battery life.This is very inconvenient to have the machine turn off in the middle of a procedure.
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Search Alerts/Recalls
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