Model Number 3100A |
Device Problems
Mechanical Problem (1384); No Pressure (2994)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/04/2023 |
Event Type
malfunction
|
Event Description
|
It was reported to vyaire medical that the 3100a ventilator will not pressurize.Furthermore, there was no patient involvement associated with the reported event.
|
|
Manufacturer Narrative
|
Vyaire medical file identification: (b)(4).H3: 81 other -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.H3 other text : device not returned yet.
|
|
Manufacturer Narrative
|
Results of investigation: vyaire medical field service representative (fsr) went on site to check and inspect the device.The root cause was determined due to loose bias flow.Checked unit and found tubing inside pneumatics that connects to the bias flow loose.As a resolution, vyaire ts was able to secured tubing and the unit pressurized.
|
|
Search Alerts/Recalls
|