AVEA VENTILATOR Adverse Event — Injury (MDR 2021710-2020-11775)
AVEA VENTILATOR Adverse Event — Injury (MDR 2021710-2020-11775) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AVEA VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: VYAIRE MEDICAL.
| Device | AVEA VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2021710-2020-11775 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | AN ONSITE PERSONNEL FOUND OUT THAT THERE WAS A LEAK IN EXHALATION CORNER. HE TOOK IT APART AND RESET IT ALL WITH 2% LEAK VOLUMES BACK TO NORMAL. HE ALSO FIXED THE PEEP BY TURNING EXH VALVE. A TEST WAS CONDUCTED AND THE DEVICE WAS RUNNING WELL AS IT SHOULD ACCORDING TO SPECIFICATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION |
| Source | openFDA MAUDE (device adverse events) |
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