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Model Number 9770501 |
Device Problems
Defective Device (2588); Application Program Freezes, Becomes Nonfunctional (4031)
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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.
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Event Description
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Per tm: the unit freezes and cuts off.
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Event Description
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Per tm: the unit freezes and cuts off.
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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 the unit freezes and cuts off is unconfirmed.The scanner ran for a couple hours and never did 'freeze' or 'cut off'.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 product complaint(s) from this serial number.
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Search Alerts/Recalls
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