Device Problem
Device Stops Intermittently (1599)
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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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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 a power (intermittent power) issue.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 05/02/2016.Correction to suspect medical device serial #.
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Manufacturer Narrative
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Device evaluation: the pump was returned and evaluated by product analysis on 06/28/2016 with the following findings: animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.During testing, the pump did not power on appropriately, but rather emitted a single audible tone with a blank screen.The pump case was removed, and the internal u22 component was found to be damaged.Further testing of the intermittent power complaint could not be completed due to the failed component.(b)(4).
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Search Alerts/Recalls
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