VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11768)
VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11768) 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 | 2021710-2020-11768 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, PHOTOGRAPH AND LOGS OF THE VENTILATOR HAS BEEN SENT BY THE CUSTOMER FOR REVIEW. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME, SINCE THE INVESTIGATION HAS NOT STARTED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION WAS RECEIVED. |
| Source | openFDA MAUDE (device adverse events) |
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