FDA Adverse Event
Injury
Summary report: N
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
MDR report key: 2625800
·
Received December 1, 2009
Report
- Report Number
- 1725056-2009-00001
- Event Type
- Injury
- Date Received
- December 1, 2009
- Date of Event
- October 28, 2009
- Report Date
- December 1, 2009
- Manufacturer
- MEDIVANCE, INC.
- Product Code
- DWJ
- PMA / PMN Number
- K010338
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AT THE CUSTOMER SITE BY THE HOSPITAL BIOMEDICAL ENGINEERING STAFF IN CONSULTATION WITH MEDIVANCE TECHNICAL SUPPORT. THE HOSPITAL BIOMEDICAL STAFF REPORTED TO MEDIVANCE THAT THE DEVICE WAS FOUND TO BE PROPERLY CALIBRATED AND PERFORMING WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
THE PT WAS ADMITTED TO THE NEURO-INTENSIVE CARE UNIT FOR CEREBRAL BLEED. ON (B)(6) 2009, THE PT WAS PLACED ON THE ARCTIC SUN TEMPERATURE MGMT SYSTEM FOR NEUROGENIC FEVER MGMT. ON (B)(6) 2009 BLISTERS WERE NOTED ON THE PT'S BACK AND THIGHS, WHICH REQUIRED DEBRIDEMENT AND TREATMENT WITH SILVADENE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM | TEMPERATURE MANAGEMENT SYSTEM | DWJ | MEDIVANCE, INC. | 2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |