N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9848100
- MDR report key
- 9848100
- Report number
- 1018233-2020-01874
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-18
- 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
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCTICSUN 5000 | ARCTIC SUN DEVICE | MEDIVANCE, INC. ? 1725056 | DWJ | 50000000E | 50000000E | NA | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-18 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE ARCTICSUN DEVICE DISPLAYED SUBOPTIMAL FLOW RATE. THE FLOW WAS 0.4 L/MIN. PER TROUBLESHOOTING, THE PADS WERE DISCONNECTED AND DIAGNOSTICS WERE RUN. THE FLOW RATE WAS 2.5 L/MIN, THE INLET PRESSURE WAS -11 PSI, AND THE CIRCULATION PUMP WAS 50%. THE PADS WERE RECONNECTED AND THE FLOW RATE WAS 0.8 L/MIN. THE PATIENT WAS 33.6, AND THE TARGET WAS 33.5C. THE NURSE WAS ADVISED TO SWITCH OUT THE DEVICE.