Device Problem
Device Stops Intermittently (1599)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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.(b)(6).
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging a power (intermittent power) issue.There was no additional information available for this complaint.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.
|
|
Manufacturer Narrative
|
Follow-up #1: date of submission 06/10/2016.Device evaluation: the device has been returned and evaluated by product analysis on 05/23/2016 with the following findings: a review of the black box revealed unexplained "power on reset" events on 03/08/2016 and 03/11/2016.The battery compartment was found to be intact.The battery cap width and height measurements were within specifications.The battery cap tightly secured to the pump.The pump was powered on with the returned battery cap.The pump was exercised with the returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated.The pump case was removed; there was no evidence of moisture or loose components found inside the pump.The "intermittent power" complaint was not duplicated during investigation.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.
|
|
Search Alerts/Recalls
|