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Model Number 382400 |
Device Problems
Leak/Splash (1354); Device Displays Incorrect Message (2591); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Submit date: 12/29/2016.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 has an issue with an epump.The customer states the unit displays an error alarm.However, upon triage, worn shaft of the leaky gearbox was found, making this complaint reportable.
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Manufacturer Narrative
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The unit was triaged and the customer¿s reported condition was confirmed.The root cause is due to worn shaft of the leaky gearbox 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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