Model Number 3100A |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/09/2022 |
Event Type
malfunction
|
Event Description
|
It was reported to vyaire medical that the 3100a ventilator could not get the zero in specification.Now the zero is coming in specification fine but he cannot get any map (mean airway pressure).As of this time there is no information about patient involvement associated with this reported event.
|
|
Manufacturer Narrative
|
Vyaire file identification: (b)(6).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
|
|
Event Description
|
It was reported to vyaire medical that the 3100a ventilator could not get the zero in specification.Now the zero is coming in specification fine but he cannot get any map (mean airway pressure).As of this time there is no information about patient involvement associated with this reported event.
|
|
Manufacturer Narrative
|
Vyaire file identification: (b)(6).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
|
|
Search Alerts/Recalls
|