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.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.
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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 04/08/2016-product analysis: the device was returned and evaluated by product analysis on 03/28/2016 with the following findings: the complaint could not be duplicated or confirmed with investigation.Review of the pump¿s black box revealed no related issues.A battery compartment crack was observed.The returned battery cap was able to secure properly to the pump without power issue.The cap¿s contact dimensions were within specification and the cap was undamaged.The pump successfully completed a prime sequence and 24-hour exercise test without issue or alarm.No damage or defect was found to the pump¿s internal components.Unrelated to the complaint, investigation revealed the display screen was dim and discolored.
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Search Alerts/Recalls
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