MAUDE Adverse Event Report: CAIRE INC. CAIRE LIBERATOR 45; UNIT, LIQUID OXGYEN, STATIONARY

Model Number 14807323

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 05/13/2017

Event Type  Injury  

Manufacturer Narrative

The company is attempting to get the unit returned for investigation.If the unit is evaluated a follow-up report will be submitted.

Event Description

The company was informed on (b)(6) 2017 of an adverse event that occurred on (b)(6) 2017.The patient was filling a portable liquid oxygen unit from a stationary liquid oxygen unit.When the portable unit was removed, the valve did not close properly and the fire alarm went off.The patient attempted to clear the ice away with hot water, which resulted in a burn to the right hand.

Event Description

Other than the screws that secure the fcv to the manifold bracket being loose, the unit is within all manufacturers' specifications.The alleged incident reported could not be duplicated.

• Brand Name: CAIRE LIBERATOR 45
• Type of Device: UNIT, LIQUID OXGYEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7707217700
• MDR Report Key: 6629248
• MDR Text Key: 77275593
• Report Number: 3004972304-2017-00013
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K800742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14807323
• Device Catalogue Number: 14807323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR