Model Number 382401 |
Device Problems
No Audible Alarm (1019); Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Submit date: 10/3/2016.An investigation is currently under way; upon completion the results will be forwarded.
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Event Description
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T was reported to covidien that a customer had an issue with an enteral feeding pump.On (b)(6) 2016 the customer states the unit has a system error.Upon triage on (b)(6) 2016 the service tech found the unit would not alarm.
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Manufacturer Narrative
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An evaluation of the kangaroo epump was performed for the reported condition of, ¿the service technician founding of no alarm.¿ it was noted that there was a dislodged component from the pcb causing the unit to not alarm.A trend has been identified and a corrective action has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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