Device Problems
Electrical /Electronic Property Problem (1198); Moisture Damage (1405)
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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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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging that the pump had no power.The reporter stated that there was moisture behind the display screen.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up #1: date of submission 02/01/2017 device evaluation: the device has been returned and evaluated by product analysis on 01/07/2017 with the following findings: there were multiple pump reboot events observed in the pump history on (b)(6) 2016.The pump powered on to a blank display screen.Moisture corrosion was observed on the display screen.Further moisture was fond on the internal components of the pump.
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Search Alerts/Recalls
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