MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for EVERFLOW 1020000 manufactured by Respironics, Inc..
[176638962]
The device was the "area of origin" of a fire. This investigator was unable to determine if the unit was the cause of the fire or damaged due to the fire. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092560 |
| MDR Report Key | 9638291 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-14 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERFLOW |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-01-28 |
| Model Number | 1020000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |