Model Number 383401 |
Device Problems
Defective Alarm (1014); Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Submit date: 09/20/2016.An investigation is currently underway.Upon completion, a full report shall be provided.
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Event Description
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It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer reports that the unit shut down while plugged in.The unit did not provide warning to the customer that the unit was shutting down.There was no patient involvement as the issue occurred during testing.
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Manufacturer Narrative
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An evaluation of the kangaroo joey pump was performed for the reported condition of the unit is shutting down.The unit was triaged and the reported issue could not be confirmed at this time.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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