AVEA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11815)
AVEA VENTILATOR Adverse Event — Malfunction (MDR 2021710-2020-11815) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AVEA VENTILATOR; Generic name: VENTILATOR, HIGH FREQUENCY; Manufacturer: VYAIRE MEDICAL.
| Device | AVEA VENTILATOR |
|---|---|
| Generic name | VENTILATOR, HIGH FREQUENCY |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11815 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, USER F |
| Narrative | (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. HOWEVER, THE CUSTOMER TRACED THE PROBLEM TO A DEFECTIVE POWER SUPPLY ASSEMBLY. 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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