N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9853234
- MDR report key
- 9853234
- Report number
- 1018233-2020-01917
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-19
- 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 | 50000000 | 50000000 | NA | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-19 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS A DEVICE SENSING ISSUE ON THE ARCTIC SUN DEVICE. THE PATIENT TARGET WAS 33C BUT THEY STARTED TO SHIVER AND INCREASED TO 34.5C. THEY ADMINISTERED NMB AND FENTANYL BOLUSES, BUT TEMPERATURE REMAINED AT 34.5C. THERE WAS GOOD FLOW AND FIT TO PADS. WATER WAS 5C AND TREND WAS THREE ARROWS DOWN. MS&S EXPLAINED THE DEVICE WAS WORKING APPROPRIATELY AND EXPLAINED THE TREND.