FDA Adverse Event
Malfunction
Summary report: N
MAXITHERM LITE
MDR report key: 933402
·
Received April 11, 2007
Report
- Report Number
- 1516825-2007-00003
- Event Type
- Malfunction
- Date Received
- April 11, 2007
- Date of Event
- January 22, 2007
- Report Date
- March 22, 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 THE NURSE FOUND THE LINENS AND FLOOR WERE WET. NEW BLANKETS WERE OBTAINED. USER FACILITY REPORTED THAT THE PATIENT'S TEMPERATURE DECREASED APPROXIMATELY 0.1 DEGREE CELSIUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXITHERM LITE | HYPER-HYPOTHERMIA BLANKET | DWJ | CINCINNATI SUB-ZERO | 874 | 7796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO |