FDA Adverse Event
Summary report: N
WARM AIR
MDR report key: 1711991
·
Received June 1, 2010
Report
- Report Number
- 1711991
- Date Received
- June 1, 2010
- Date of Event
- February 15, 2010
- Report Date
- June 1, 2010
- Manufacturer
- CINCINNATI SUB-ZERO PRODUCTS, INC.
- Product Code
- DWJ
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
A NEW WARMING UNIT AND BLANKET WAS BEING TRIALED DURING SURGERY. HOSE TO WARMING BLANKET WAS PADDED WITH TOWEL AND WAS NOT DIRECTLY ON THE PATIENT'S BODY. AT THE END OF THE PROCEDURE, THE PATIENT'S RIGHT KNEE FROM MID UPPER RIGHT THIGH TO MID LOWER CALF WAS REDDENED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================POSSIBLY THE CONNECTION WAS TAPED SO THAT THE TAPE/TENSION TORE PART OF THE PAPER AROUND THE CONNECTION AND THEREFORE AIR COULD ESCAPE AND BLOW DIRECTLY ON THE PATIENT; OR THE CONNECTION CAME APART AND BLEW DIRECTLY ON PATIENT; AND THE BLANKET NOT ABLE TO BE CHECKED UNDER STERILE DRAPES DURING SURGERY FOR PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WARM AIR | WARMING UNIT | DWJ | CINCINNATI SUB-ZERO PRODUCTS, INC. | 135 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | NO OTHER THERAPIES |