MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-17 for VITAL SIGNS? PEDIATRIC ANESTHESIA BREATHING CIRCUIT B1714XXX manufactured by Vyaire Medical.
[145511844]
Vyaire complaint : (b)(4). At this time, vyaire medical has not received the suspect device for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145511845]
Customer reported that one box of circuits were found to be "falling apart". Hoses keep popping off while in use. No patient compromise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2019-00042 |
| MDR Report Key | 8622131 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-17 |
| 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 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA V # 85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI, MEX 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS? PEDIATRIC ANESTHESIA BREATHING CIRCUIT |
| Generic Name | ANESTHESIA BREATHING CIRCUIT |
| Product Code | CAI |
| Date Received | 2019-05-17 |
| Catalog Number | B1714XXX |
| Lot Number | 0004052958 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-05-17 |