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Model Number 9770501 |
Device Problems
Failure to Charge (1085); Battery Problem (2885)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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 device has not been received by the manufacturer, at this time, for evaluation.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.Device has not been received, at this time.
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Event Description
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Per biomed, battery does not hold a charge.At 95% on boot up and shuts down at 90%.
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Event Description
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Per biomed, battery does not hold a charge.At 95% on boot up and shuts down at 90%.
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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 shutting down abruptly was confirmed.The scanner shuts down prematurely after the power supply is unplugged.The root cause of the failure was identified as an internal failure in the lithium ion battery.No other functionality issues with the equipment were found during evaluation/servicing.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 biomed, battery does not hold a charge.At 95% on boot up and shuts down at 90%.
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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 shutting down abruptly was confirmed.The scanner shuts down prematurely after the power supply is unplugged.The root cause of the failure was identified as an internal failure in the lithium ion battery.No other functionality issues with the equipment were found during evaluation/servicing.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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Search Alerts/Recalls
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