Model Number IPN041365 |
Device Problem
Obstruction of Flow (2423)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/07/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that " during induction of a child, no capnia value/measurement was displayed on the ventilator because the filter was blocked.Patient was reported as fine post the procedure.No reported patient harm.Associated to 8040412-2023-00398.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Manufacturer Narrative
|
(b)(4) the sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "based on the investiga tion conducted on the returned sample, luer port of the complaint product housing has occluded by the housing material.The mentioned product housing was supplied by our supplier, and hence supplier corrective action request (scar) and nc has been issued, root cause analysis and identified corrective actions will be implemented through this scar.Assembly process will be conducted in our manuf acturing site for the product after receive the part item from supplier.".
|
|
Event Description
|
It was reported that " during induction of a child, no capnia value/measurement was displayed on the ventilator because the filter was blocked.Patient was reported as fine post the procedure.No reported patient harm.Associated to (b)(6).
|
|
Search Alerts/Recalls
|