FDA Adverse Event
Injury
Summary report: N
CAIRE
MDR report key: 3354724
·
Received September 16, 2013
Report
- Report Number
- 3004822415-2013-00013
- Event Type
- Injury
- Date Received
- September 16, 2013
- Date of Event
- August 14, 2013
- Report Date
- September 13, 2013
- Manufacturer
- CAIRE, INC.
- Product Code
- BYJ
- PMA / PMN Number
- K800742A
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT VIA EMAIL BY VITALAIRE (B)(4) ON (B)(6) 2013. THE EMAIL DESCRIBES THE ALLEGED INCIDENT AS THE FOLLOWING: THE OPERATOR FILLED THE PORTABLE UNIT OF HIS WIFE ((B)(4)) WITH THE ABOVE MENTIONED BASE UNIT. AFTER FINISHING FILLING THE QDV DID NOT CLOSE COMPLETELY AND LIQUID OXYGEN CAME OUT OF THE BASE UNIT. THE OPERATOR TRIED TO CLOSE THE QDV HIMSELF AND RECEIVED BURNS THAT WERE TREATED BY A DOCTOR THAT NEXT DAY. THE OPERATOR CALLED THE FIRE DEPARTMENT AND THEY BROUGHT THE UNIT OUTSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465302 | CAIRE | UNIT, LIQUID OXYGEN, BASE, RESERVOIR | BYJ | CAIRE, INC. | 14454994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |