AVEA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11831)
AVEA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11831) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AVEA VENTILATOR; Generic name: VENTILATOR, HIGH FREQUENCY; Manufacturer: VYAIRE MEDICAL.
| Device | AVEA VENTILATOR |
|---|---|
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11831 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. |
| Source | openFDA MAUDE (device adverse events) |
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