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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 will not be returned to the manufacturer for evaluation, as the device is being retained by the reporting facility at this time.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 picc nurse, machine not holding a charge, and turning off during procedures.
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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 machine not holding a charge, and turning off during procedures was confirmed.During inspection the unit was fully charged and ran on battery power for twenty minutes, the root cause of the issue is an internal battery failure causing the unit to have a premature discharge of the battery.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 picc nurse, machine not holding a charge, and turning off during procedures.
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Event Description
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Per picc nurse, machine not holding a charge, and turning off during procedures.
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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 machine not holding a charge, and turning off during procedures was confirmed.During inspection the unit was fully charged and ran on battery power for twenty minutes, the root cause of the issue is an internal battery failure causing the unit to have a premature discharge of the battery.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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