N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 9844626
- MDR report key
- 9844626
- Report number
- 1018233-2020-01868
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- 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 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-17 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS INSUFFICIENTLY COOLING. THE DEVICE DISPLAYED AN ALERT 113. THE PATIENT TEMPERATURE WAS 40.5C, THE WATER TEMPERATURE WAS 30.5C, AND THE FLOW RATE WAS 2.6LPM. THE TARGET TEMPERATURE WAS 37C. THE DEVICE WAS SENT TO BIOMED. T1 WOULD NOT DROP BELOW 20C. PER FOLLOW UP, THE DEVICE WAS TO BE SENT IN FOR PREVENTIVE MAINTENANCE.