MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-14 for EVERFLO OXYGEN CONCENTRATOR 1020000 manufactured by Respironics, Inc..
| Report Number | 1040777-2019-00047 |
| MDR Report Key | 9186326 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-09 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2019-10-09 |
| Device Manufacturer Date | 2015-12-03 |
| Date Added to Maude | 2019-10-14 |
| 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 | ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal | 15068 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | RESPIRONICS, INC. |
| Manufacturer Street | 175 CHASTIAN MEADOWS COURT |
| Manufacturer City | KENNESAW GA 301443724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 301443724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERFLO OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2019-10-14 |
| Model Number | 1020000 |
| Catalog Number | 1020000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 175 CHASTIAN MEADOWS COURT KENNESAW GA 301443724 US 301443724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-14 |