|
Model Number 382400 |
Device Problem
No Display/Image (1183)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/01/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that an issue occurred with an enteral feeding pump.After receiving confirmation on (b)(6) 2018 from the customer, the screen was not legible.Issue discovered during testing.No patient was involved.
|
|
Manufacturer Narrative
|
An evaluation of the kangaroo epump was performed and the customer states ¿the screen was not legible.¿ the unit was triaged and the customer¿s reported condition was confirmed.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
|
|
|