MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-10 for VITAL SIGNS? CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA M1152225 manufactured by Vyaire Medical.
| Report Number | 3004050971-2019-00003 |
| MDR Report Key | 9176743 |
| Date Received | 2019-10-10 |
| Date of Report | 2019-08-29 |
| Date of Event | 2019-08-28 |
| Date Mfgr Received | 2019-11-18 |
| Date Added to Maude | 2019-10-10 |
| 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 | 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, 523730 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS? CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN WITH GA |
| Generic Name | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
| Product Code | CAI |
| Date Received | 2019-10-10 |
| Model Number | BREATHING CIRCUIT |
| Catalog Number | M1152225 |
| Lot Number | 182633 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-10-10 |