Device Problems
Device Alarm System (1012); Vibration (1674)
|
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.
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas, alleging an audio tone/vibration (dual alarm failure) 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.
|
|
Manufacturer Narrative
|
Device evaluation: the pump has been returned and evaluated by product analysis on 05/23/2016 with the following findings: during investigation, the audible and vibratory alarms functioned appropriately.The pump was opened and the no damage was observed to the piezo or vibration motor circuit.The complaint of a dual alarm failure issue was not duplicated during investigation.There was no defect found.
|
|
Search Alerts/Recalls
|