Model Number 383400 |
Device Problems
Self-Activation or Keying (1557); Device Stops Intermittently (1599)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Submit date: 02/06/2017.An investigation is currently underway.Upon completion, the results will be forwarded.
|
|
Event Description
|
It was reported to covidien on 01/25/2017 that an issue occurred with an enteral feeding pump.The customer reports the unit turns on and off on its own.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
An evaluation of the kangaroo pump was performed and the customer states ¿the unit turns on and off on its own.¿ the unit was triaged and the reported issue could not be confirmed at this time.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|