FDA Adverse Event
Malfunction
Summary report: N
MAXI-THERM
MDR report key: 966565
·
Received December 12, 2007
Report
- Report Number
- 966565
- Event Type
- Malfunction
- Date Received
- December 12, 2007
- Date of Event
- November 5, 2007
- Report Date
- December 12, 2007
- Manufacturer
- CINCINNATI SUB-ZERO PRODUCTS, INC
- Product Code
- DWJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PATIENT ON POST ARREST HYPOTHERMIA COOLING PROTOCOL WITH USE OF ADULT MAXI-THERM BLANKETS (X2). RN CARING FOR PATIENT ENTERED ROOM AT 8 PM AND NOTED WATER COMING FROM BLANKET ON TOP OF PATIENT (HAS NO LOT # WRITTEN ON IT). BLANKET REPLACED. AGAIN AT 5:15 AM THE FOLLOWING MORNING, RN WAS STANDING OUTSIDE ROOM AND HEARD WATER RUNNING ON FLOOR AND NOTED BLANKET UNDER PATIENT (WITH LOT # WRITTEN ON BLANKET # 8288) HAD HOLE IN IT. BLANKET REMOVED, BUT NOT REPLACED. BOTH BLANKETS BAGGED AND DELIVERED TO VALUE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI-THERM | PAD, HYPO/HYPERTHERMIA | DWJ | CINCINNATI SUB-ZERO PRODUCTS, INC | NA | 8288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |