Device Problems
Electrical /Electronic Property Problem (1198); Moisture Damage (1405)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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 that the pump had no power.The reporter stated that there was moisture observed behind the display.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 03/03/2017.Device evaluation: the device has been returned and evaluated by product analysis on 02/13/2017 with the following findings: the pump was returned with moisture visible through display lens.Pump is unable to power on past the hourglass.Leak test failed due to a display lens leak.Opened pump- moisture observed throughout pump casing.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
|