FDA Adverse Event
Malfunction
Summary report: N
MAXITHERM LITE
MDR report key: 933409
·
Received April 11, 2007
Report
- Report Number
- 1516825-2007-00002
- Event Type
- Malfunction
- Date Received
- April 11, 2007
- Date of Event
- January 17, 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 A MAXITHERM LITE BLANKET WAS FOUND LEAKING ONTO THE BEDDING AND FLOOR. THE PATIENT WAS REMOVED AND THE LINENS WERE REPLACED. USER FACILITY ALSO REPORTED THAT THE PATIENT'S TEMPERATURE ROSE SLIGHTLY OUT OF THE PARAMETERS FOR CURRENT WARMING PROTOCOL AND WAS RETURNED TO REQUIRED TEMPERATURE PER PROTOCOL ONCE NEW EQUIPMENT WAS ACQUIRED.
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 |