VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11750)
VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11750) 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 | 2021710-2020-11750 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | (B)(4) THE CUSTOMER IS REQUESTED TO RETURN THE SUSPECT DEVICE TO VYAIRE FOR FURTHER INVESTIGATION. AT THIS TIME, NO ROOT CAUSE HAS BEEN DETERMINED. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. |
| Source | openFDA MAUDE (device adverse events) |
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