N
Patient 1
DEVICE EVALUATION IN PROGRESS.
MAUDE MDR 9728779
- MDR report key
- 9728779
- Report number
- 3012307300-2020-01373
- Event key
- 0
- Event type
- 3
- Date received
- 2020-02-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DAVE HALVERSON
- Address
- 6000 NATHAN LANE NORTH MINNEAPOLIS, MN 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 | LEVEL 1 TRAUMA FAST FLOW - DEFLATE PRESSURE CUFF | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION | SMITHS MEDICAL ASD, INC | BSB | H2 EZ | 7204012 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-19 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING TESTING, THE PRESSURE GAUGE WAS STUCK ON "0." THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.