VELA Adverse Event — Malfunction (MDR 2021710-2020-11829)
VELA Adverse Event — Malfunction (MDR 2021710-2020-11829) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VELA; Generic name: VENTILATOR, HIGH FREQUENCY; Manufacturer: VYAIRE MEDICAL.
| Device | VELA |
|---|---|
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11829 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. HOWEVER, CUSTOMER EXAMINED THE DEVICE AND FOUND CRACK IN EXHALATION VALVE RECEPTACLE. 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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