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

Model Number 6900-SEQ

Device Problem Power Problem (3010)

Patient Problem Burn(s) (1757)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Unit is being returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

End user complained her unit could not run on dc power.Provider took unit back to his shop and tested it in his own vehicle.When he removed the dc plug from the outlet he burnt his hand on the plug in due to it being so hot.Unit is being returned for investigation.

• 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: 6851968
• MDR Text Key: 85609803
• Report Number: 3004972304-2017-00027
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6900-SEQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 27 YR