N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9873425
- MDR report key
- 9873425
- Report number
- 1018233-2020-02054
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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 | 2020-03-24 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS INSUFFICIENTLY COOLING A PATIENT. THE TARGET TEMPERATURE WAS 33C AND THE PATIENT REACHED 37.1C. THE WATER TEMPERATURE WAS 5C AND THE FLOW RATE WAS OPTIMAL. THE PATIENT WAS SEDATED BUT NOT PARALYZED. MS&S ADVISED THAT THE DEVICE WAS RESPONDING APPROPRIATELY.