Model Number 0279401200 |
Device Problem
Continuous Firing (1123)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/27/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.
|
|
Event Description
|
It was reported that there was continuous activation.
|
|
Manufacturer Narrative
|
Alleged failure: serfas activates itself.Without pressing the button.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be probe short due to fluid ingress.A broken/damaged bond of the polyimide and suction tubing causes fluid ingress to the pcb which can lead to a short circuit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that there was continuous activation.
|
|
Search Alerts/Recalls
|