Model Number INFKIT2 |
Device Problem
Protective Measures Problem (3015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/12/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg, an investigation could not be completed.This report will be updated if the device is returned to mmdg.
|
|
Event Description
|
The initial reporter stated that the pump did not make any audible sound.At the time of the complaint, the initial reporter stated that the issue occurred during testing and had not effected any patient.[complaint-(b)(4)].
|
|
Manufacturer Narrative
|
The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.When the device was returned to mmdg for evaluation, the pump did not make any audible alarms due to a failed speaker.The alarms did function as expected and could be seen on the pump screen, but they did not alarm audibly.The pump was serviced to correct the issue.
|
|
Event Description
|
The initial reporter stated that the pump did not make any audible sound.At the time of the complaint, the initial reporter stated that the issue occurred during testing and had not effected any patient.(b)(4).
|
|
Search Alerts/Recalls
|