FDA Adverse Event
Malfunction
Summary report: N
CAIRE LIBERATOR 30
MDR report key: 3770226
·
Received March 13, 2014
Report
- Report Number
- 3004822415-2014-00003
- Event Type
- Malfunction
- Date Received
- March 13, 2014
- Date of Event
- February 12, 2013
- Report Date
- March 10, 2014
- Manufacturer
- CAIRE, INC.
- Product Code
- BYJ
- PMA / PMN Number
- K800742A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SUBJECT BASE LIQUID OXYGEN DEVICE, CAIRE LIBERATOR 30 (B)(4), WAS INSPECTED AT THE CUSTOMER SITE. DURING THE ON-SITE EVALUATION, IT WAS DETERMINED THAT THE QDV WAS INADEQUATELY TIGHTENED TO PROPERLY SEAT THE FERRULE TO THE TUBE.
Description of Event or Problem · 1
THE COMPANY WAS INFORMED OF AN ALLEGED INCIDENT VIA EMAIL ON (B)(6) 2014. THE ALLEGED INCIDENT WAS DESCRIBED TO THE COMPANY AS FOLLOWED. WHILE FILING THE UNIT THROUGH THE SIDE FILL CONNECTOR, THE TOP FILL QDV DISCONNECTED AND LIQUID OXYGEN SPILLED OUT. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151871 | CAIRE LIBERATOR 30 | UNIT, LIQUID OXYGEN, BASE, RESERVOIR | BYJ | CAIRE, INC. | 13258385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |