Model Number NIMBUS II PAINPRO |
Device Problems
Mechanical Problem (1384); No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/07/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
A review of the device history record has been completed.The pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.Device return requested.This mdr will be reopened and updated in the event the device involved or additional information becomes available.
|
|
Event Description
|
On 02/07/2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.Requested device to be returned.
|
|
Manufacturer Narrative
|
Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Analysis of the returned device was completed on 4/9/2024.The results are below: the event log was reviewed, and it was confirmed that the pump alarmed system error during an infusion.This is seen on line 106.The subcode for the system error is 44 which indicates motor open and motor delay issue.During functional testing, the reported problem was duplicated.Upon beginning the infusion, the system error alert began to alarm on the pump immediately.A capa has been opened in order to fully diagnose and address the root cause of the reported event.
|
|
Search Alerts/Recalls
|