MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-10-23 for BIO-MED DEVICES OXYGEN BLENDER FOBM1000 manufactured by Biomedical Devices, Inc..
| Report Number | 3007409280-2019-00060 |
| MDR Report Key | 9228009 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-10-23 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-11-17 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2019-10-23 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNA VARGAS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-MED DEVICES OXYGEN BLENDER |
| Generic Name | BMD AIR/OXYGEN BLENDER |
| Product Code | BZR |
| Date Received | 2019-10-23 |
| Model Number | FOBM1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMEDICAL DEVICES, INC. |
| Manufacturer Address | 8 BISHOP LN. MADISON CT 06443 US 06443 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-23 |