N
Patient 1
(B)(6)
MAUDE MDR 7632625
- MDR report key
- 7632625
- Report number
- 3003604053-2018-00104
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-06-06
- Date received
- 2018-06-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JIM GONZALES
- Address
- 7000 WEST WILLIAM CANNON DR. AUSTIN TX 78735 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PUMP A127 GOFLO | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | SMITH & NEPHEW, INC. | FEQ | 72204968 | 1709CE0033 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-24 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A CALIBRATION ISSUE HAVE CAUSED HIGH FLOW. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS WITH A BACKUP DEVICE AND THERES WAS NO DELAY REPORTED.