AVEA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11773)
AVEA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11773) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AVEA VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: VYAIRE MEDICAL.
| Device | AVEA VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11773 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | VYAIRE FILE IDENTIFICATION: (B)(4). VYAIRE TECHNICAL SUPPORT ASSISTED THE CUSTOMER TO TROUBLESHOOT THE DEVICE. AFTER THE TESTS, TECHNICAL SUPPORT INFORMED CUSTOMER THAT THE GAS DELIVERY ENGINE (GDE) NEEDS TO BE REPLACED. THE SUSPECTED DEVICE/COMPONENT IS STILL UNDER INVESTIGATION. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. |
| Source | openFDA MAUDE (device adverse events) |
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