FDA Adverse Event
Summary report: N
PATIENT WARMING SYSTEM
MDR report key: 1060656
·
Received June 5, 2008
Report
- Report Number
- 1060656
- Date Received
- June 5, 2008
- Date of Event
- March 13, 2008
- Report Date
- June 5, 2008
- Manufacturer
- KIMBERLY CLARK
- Product Code
- DWJ
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE A PATIENT RECEIVED A SMALL FIRST DEGREE BURN ON THEIR BACK FROM A WARMING PAD. THE CASE WAS SEVERAL HOURS AND THE TEMP WAS OPERATING AT 41 DEGREES. IT WAS FOUND DURING A ROOT CAUSE ANALYSIS (RCA) THAT THERE WAS A DEVIATION FROM THE STANDARD USAGE OF THE WARMING PAD WITH THE USE OF A ROLLED TOWEL CAUSING THE CONCENTRATED HEAT. THE TOWEL WAS ROLLED UP AND PLACED AGAINST THE WARMING PAD. THE PATIENT'S WEIGHT, POSITION OF THE PATIENT (ROLLED ON SIDE TO PROVIDE ACCESS DURING PROCEDURE) AND THE TOWEL FORCED THE WARMING PAD TIGHTER TO THE PATIENTS SKIN CAUSING A BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATIENT WARMING SYSTEM | HYPO/HYPERTHERMIA UNIT | DWJ | KIMBERLY CLARK | M1000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |