VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11766)
VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11766) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VELA VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: VYAIRE MEDICAL.
| Device | VELA VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11766 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | 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. |
| Source | openFDA MAUDE (device adverse events) |
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