MAUDE MDR 9056661
- MDR report key
- 9056661
- Report number
- 2031642-2019-09278
- Event key
- 0
- Event type
- 3
- Date received
- 2019-09-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | RESPIRONICS CALIFORNIA, INC | MNS | NA | | | | | | Y
| Y |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-09-14 | 0 |
|
Event Narratives#
No narrative records found.