VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11767)
VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11767) 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 | 2021710-2020-11767 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | DEVICE EVALUATION: D10, G4, G7, H2, H6 AND H10 RESULT OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED COMPLAINT WAS NOT ABLE TO CONFIRMED AND DUPLICATED. VISUALLY INSPECTED FRONT PANEL, FOUND NO ANOMALIES. DISPLAY CAME ON WITHOUT FAULT EVERY TIME. |
| Source | openFDA MAUDE (device adverse events) |
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