VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11741)
VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11741) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VELA VENTILATOR; Generic name: VENTILATOR, HIGH FREQUENCY; Manufacturer: VYAIRE MEDICAL.
| Device | VELA VENTILATOR |
|---|---|
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11741 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. THEREFORE NO ROOT CAUSE CAN BE ESTABLISHED. |
| Source | openFDA MAUDE (device adverse events) |
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