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Model Number 9770501 |
Device Problem
Charging Problem (2892)
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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 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, unit will not hold a charge.'not holding a charge to the point where they cannot complete a picc if the machine is not plugged in'.
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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 will not hold a charge is confirmed.The scanner shuts down after ac power is removed.The root cause of the reported issue is an internal li-ion battery failure.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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Event Description
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Per tm, unit will not hold a charge.'not holding a charge to the point where they cannot complete a picc if the machine is not plugged in'.
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Search Alerts/Recalls
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