FDA Adverse Event
Other
Summary report: N
FINAL LIBERATOR 45 TF PB
MDR report key: 1511730
·
Received October 16, 2009
Report
- Report Number
- 3004822415-2009-00002
- Event Type
- Other
- Date Received
- October 16, 2009
- Date of Event
- September 10, 2009
- Report Date
- September 18, 2009
- Manufacturer
- CAIRE, INC.
- Product Code
- BYJ
- PMA / PMN Number
- K800742
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CAIRE, INC. HAS REQUESTED THE UNIT BE RETURNED FOR EVAL AND TESTING.
Description of Event or Problem · 1
PT'S DAUGHTER STATED THAT AFTER FILLING A PORTABLE LOX UNIT, THE LIBERATOR 45 STATIONARY UNIT FROZE OPEN. IN AN ATTEMPT TO CLOSE THE OPEN FILL PORT ON THE STATIONARY UNIT, THE PT'S DAUGHTER CAME INTO CONTACT WITH LOX, CAUSING A BURN ON HER HAND. DAUGHTER WAS TREATED IN ER FOR BURNS ON 3 FINGERS (2ND DEGREE BURN ON 1 FINGER, AND 1ST DEGREE BURN ON 2 FINGERS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINAL LIBERATOR 45 TF PB | LOX BASE UNIT | BYJ | CAIRE, INC. | LIBERATOR 45 TF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |