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 2019-01-25 for RESUS, PED W/MASK, RESV BAG 2K8040 manufactured by Vyaire Medical.
[134335803]
Due to limited information, no samples and/or lot numbers were provided by the customer. Vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[134335804]
Customer reported: nursing said that they had to use canulaid more often compared to the old version of cannulas. Despite the addition of canulaid, a patient had nasal injuries reported; one with a malformation after therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2019-00026 |
| MDR Report Key | 8278215 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-01-25 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-01-25 |
| 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 UR |
| Manufacturer Street | CERRADA V 85 PARQUE UNDUSTRIAL MEX III |
| 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 | RESUS, PED W/MASK, RESV BAG |
| Generic Name | MANUAL EMERGENCY VENTILATOR |
| Product Code | OEV |
| Date Received | 2019-01-25 |
| Catalog Number | 2K8040 |
| Lot Number | 0001143879 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-25 |