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

Model Number 6900-SEQ

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Popping/gurgling smell that doesn't sound the same as the humming.When the gurgling noise started then the user noticed the smell.(b)(4) told the user to turn the unit off.After 30 minutes the user turned the unit back on and it was still making the gurgling sound and proceeded to turn the unit off again.User feels that a fire must be inside the unit to make that kind of smell, worried about running the unit more because of smell.Unit will run.User has had the unit for a couple of weeks.

Manufacturer Narrative

The unit was returned and evaluated.During testing, the uut did not exhibit any signs of a malfunction.The unit produced adequate purity, within the 87 - 95.5% specification for the unit and the product pressure was within the 4.1 - 10 psi specification.Additionally, the unit charged its battery and operated on battery power adequately.The unit did not produce any burning or other abnormal smells during testing.Additionally, there were no popping, gurgling, or other abnormal sounds produced by the unit during testing.Finally, the unit did not produce or smoke or show any signs of smoke or burning during testing.However, there was some slight burning/heat discoloration on the wire insulation in the dc power plug.

• 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
• MDR Report Key: 7088845
• MDR Text Key: 94506714
• Report Number: 3004972304-2017-00048
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K013931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6900-SEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1