MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-12-26 for AIRLIFE? GAS INJECTION NEBULIZER (GIN) 441G manufactured by Vyaire Medical.
| Report Number | 8030673-2019-00062 |
| MDR Report Key | 9522080 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-12-26 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2017-04-25 |
| Date Added to Maude | 2019-12-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION 85 INDUSTRIAL MEXICALI |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE? GAS INJECTION NEBULIZER (GIN) |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2019-12-26 |
| Returned To Mfg | 2020-02-20 |
| Model Number | AIRLIFE? GAS INJECTION NEBULIZER (GIN) |
| Catalog Number | 441G |
| Lot Number | 001086304 |
| 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 | 1. Other | 2019-12-26 |