MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for DEVILBISS 1025DS manufactured by Devilbiss Healthcare.
| Report Number | 2515872-2019-00005 |
| MDR Report Key | 9142102 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-09-27 |
| Date of Event | 2019-08-28 |
| Date Facility Aware | 2019-08-28 |
| Report Date | 2019-09-16 |
| Date Reported to Mfgr | 2019-09-16 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2019-04-26 |
| Date Added to Maude | 2019-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | MS FIGUEROA |
| Manufacturer Street | 100 DEVILBISS DRIVE |
| Manufacturer City | SOMERSET PA 15501 |
| Manufacturer Country | US |
| Manufacturer Postal | 15501 |
| Manufacturer G1 | DEVILBISS HEALTHCARE |
| Manufacturer Street | 100 DEVILBISS DRIVE |
| Manufacturer City | SOMERSET PA 15501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEVILBISS |
| Generic Name | OXYGEN CONCENTRATOR |
| Product Code | CAW |
| Date Received | 2019-10-01 |
| Model Number | 1025DS |
| Catalog Number | 1025DS |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVILBISS HEALTHCARE |
| Manufacturer Address | 100 DEVILBISS DRIVE SOMERSET PA 15501 US 15501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-01 |