MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-13 for NEV-100 100 12-001 manufactured by Phillips Respironics.
[2157084]
Nev 100 is the only machine in america that can run daughter's port-lung. It is considered discontinued now. Philips respironics will not share schematics, or parts. Machine is broken and they will not repair it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022255 |
| MDR Report Key | 2254769 |
| Date Received | 2011-09-13 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-09-09 |
| Date Added to Maude | 2011-09-20 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEV-100 |
| Generic Name | NEGATIVE PRESSURE VENTILATOR |
| Product Code | BYT |
| Date Received | 2011-09-13 |
| Model Number | 100 12-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS RESPIRONICS |
| Manufacturer Address | CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2011-09-13 |