N
Patient 1
MAUDE MDR 6965120
- MDR report key
- 6965120
- Report number
- 6965120
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-05
- Date received
- 2017-10-20
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OXYGEN FLOWMETER | FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED | PRECISION MEDICAL, INC. | CAX | 0197 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-20 | 0 |
Event Narratives#
D
Patient 1
PATIENT WAS ON 4L/NC O2 AND HIS SATS WERE 61%. O2 WAS ON. THE REGULATORY WAS CHANGED OUT AND THE PATIENT'S SATS WENT UP TO 91%.