MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-31 for AVEA VENTILATOR 17311-00 manufactured by Vyaire Medical.
[146638729]
A vyaire field service representative (fsr) went onsite to evaluate the device. The gas delivery engine (gde) was removed and the ribbon cables were reseated. The fsr could not confirm the problem reported with the inaccurate fio2 values. The device was tested and the field service rep confirmed it passed all testing and met all vyaire manufacturer specifications.
Patient Sequence No: 1, Text Type: N, H10
[146638730]
It was reported to vyaire that they fio2 was inaccurate and was not able to be corrected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2019-10307 |
| MDR Report Key | 8658084 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-08-23 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2019-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | VYAIRE MEDICAL INC. |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVEA VENTILATOR |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CBK |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-05-10 |
| Model Number | AVEA |
| Catalog Number | 17311-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |