MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-13 for AIRFLOW AF1140MB manufactured by Sunmed Holdings Llc..
| Report Number | 1314417-2020-00015 |
| MDR Report Key | 9829044 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-14 |
| Date Added to Maude | 2020-03-13 |
| 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 | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW. SUITE A |
| Manufacturer City | GRAND RAPIDS, MI |
| Manufacturer Country | US |
| Manufacturer Phone | 2598400 |
| Manufacturer G1 | SUNMED HOLDINGS LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. NW SUITE A |
| Manufacturer City | GRAND RAPIDS, MI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRFLOW |
| Generic Name | MANUAL RESUSCITATOR |
| Product Code | BTM |
| Date Received | 2020-03-13 |
| Model Number | AF1140MB |
| Lot Number | 317773 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED HOLDINGS LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. NW SUITE A GRAND RAPIDS, MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |