Model Number 383400 |
Device Problems
Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Submit date: 12/14/2016.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 on (b)(6) 2016 that a customer had an issue with an enteral feeding pump.The customer states that the generated feed is not consistent.The customer tested the pump and found the feeding to be off.
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Manufacturer Narrative
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An evaluation of the kangaroo joey pump was performed for the reported condition of ¿generated feed is not consistent.¿ the unit was triaged and the customer¿s reported condition was confirmed.Through troubleshooting it was determined that the pumps ultrasonic sensor and down revision software caused the inconsistent feed volumes to be delivered.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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Search Alerts/Recalls
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