Model Number 382400 |
Device Problems
Device Emits Odor (1425); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Submit date: 09/27/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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It was reported to covidien that an issue occurred with an enteral feeding pump.On (b)(6) 2016 the customer stated that the unit displays error codes during recertification.Upon triage on (b)(6) 2016 the service tech found the unit smelled like smoke.
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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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Manufacturer Narrative
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An evaluation of the kangaroo pump was performed for the condition of a service finding of ¿a burning smell and components burnt during triaging¿.The service technician's findings were confirmed.There was evidence of liquid ingress on the main pcb which caused component to corrode.This is the result of customer misuse.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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