Model Number 8120 |
Device Problems
Pumping Stopped (1503); Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/22/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that there were multiple events wherein the pumps were alarming and shutting off.There were patients involved but no harm.
|
|
Manufacturer Narrative
|
A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.
|
|
Manufacturer Narrative
|
Additional information: imdrf annex a and g codes.
|
|
Event Description
|
It was reported that there were multiple events wherein the pumps were alarming and shutting off.There were patients involved but no harm.
|
|
Search Alerts/Recalls
|