MAUDE Adverse Event Report: CAIRE INC. ECLIPSE 5; CONCENTRATOR, OXYGEN, TRANSPORTABLE

Model Number 6900C-SEQ

Device Problems Thermal Decomposition of Device (1071); Battery Problem (2885)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.If any new information is discovered, a follow up mdr will be submitted.

Event Description

The company was informed on (b)(6) 2018 of a product problem.The unit has burn marks inside the battery compartment.It seems that the unit "caught on fire" because of the battery.It is unknown if the unit was running on ac/dc or battery power.The unit has been sitting in a warehouse for a couple of months.

Manufacturer Narrative

Unit was returned for evaluation.The battery used with the unit was not provided for testing, so it cannot be determined whether the damage was caused by the battery or battery bridge board.The unit under test had several indicators of burning including melted plastic, charring on the battery bridge board, and a smoke odor.This damage was limited to the battery compartment in the unit.The unit did not undergo functional testing because of the strong smoke odor.All components inside the unit did not show any signs of damage, aside from the battery bridge board and a slight discoloration on the compressor communication connector.

• Brand Name: ECLIPSE 5
• Type of Device: CONCENTRATOR, OXYGEN, TRANSPORTABLE
• 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: 8204571
• MDR Text Key: 131660720
• Report Number: 3004972304-2018-00059
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6900C-SEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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