|
Model Number 3100A VENT,115V,60HZ,DOM |
Device Problem
No Device Output (1435)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/26/2024 |
Event Type
malfunction
|
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.
|
|
Event Description
|
It was reported to vyaire medical that the unit will not completely power off but the screens will freeze and the driver stops, and then will start back up again on its own.No patient involvement was reported.
|
|
Search Alerts/Recalls
|
|
|