MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-03 for AIRLIFE?HMEF 750/S, DISPOSABLE M1004132 manufactured by Vyaire Medical.
| Report Number | 3004050971-2019-00002 |
| MDR Report Key | 8956452 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-03 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-08-02 |
| Date Mfgr Received | 2019-09-26 |
| Date Added to Maude | 2019-09-03 |
| 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 | 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 | VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD |
| Manufacturer Street | 45-46 SHABU INDUSTRIAL ZONE QIAO LONG DISTRICT, TANGXIA |
| Manufacturer City | DONGGUAN, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE?HMEF 750/S, DISPOSABLE |
| Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| Product Code | CAH |
| Date Received | 2019-09-03 |
| Catalog Number | M1004132 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-09-03 |