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Model Number 383400 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Submit date: 5/11/2017.
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Event Description
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It was reported to covidien that a customer had an issue with an enteral feeding pump.Upon triage, on (b)(6) 2017, service found the unit had a burnt component.
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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 reported condition of burnt component.The unit was triaged and the reported issue was confirmed.The potential root causes are the use of an unauthorized power adapter by the user and/or a possibly defective component.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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