FDA Adverse Event
Malfunction
Summary report: N
MAXITHERM LITE
MDR report key: 864276
·
Received March 22, 2007
Report
- Report Number
- 1516825-2007-00001
- Event Type
- Malfunction
- Date Received
- March 22, 2007
- Date of Event
- January 18, 2007
- Report Date
- February 23, 2007
- Manufacturer
- CINCINNATI SUB-ZERO
- Product Code
- DWJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED TO CINCINNATI SUB-ZERO. NO CONCLUSION CAN BE MADE AT THIS TIME. CSZ WILL MAKE FURTHER ATTEMPTS TO RETRIEVE DEVICE FOR EVALUATION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT A MAXI THERM LITE BLANKET LEAKED ONTO THE FLOOR. THE BLANKET WAS NOT BEING USED ON A PT AT THE TIME BUT RATHER WAS SITTING ON TOP OF A PIECE OF EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXITHERM LITE | HYPER-HYPOTHERMIA BLANKET | DWJ | CINCINNATI SUB-ZERO | 874 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | BLANKETROL |