VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11898)
VELA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11898) 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 | 2021710-2020-11898 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR, HEALTH PROFESSION |
| Narrative | (B)(4). RESULTS OF INVESTIGATION: THE VYAIRE FACTORY SERVICE DEPT. RECEIVED THE SUSPECT COMPONENT AND PERFORMED AN INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED AND DUPLICATED. THE PROBLEM WAS ISOLATED TO A FAILED PT800 TRANSDUCER. CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS THE ISSUE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATI |
| Source | openFDA MAUDE (device adverse events) |
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