MAUDE Adverse Event Report: CAIRE INC. COMPANION 5; CONCENTRATOR, OXYGEN, STATIONARY

Model Number 15067005

Device Problem Environmental Particulates (2930)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

The concentrator was plugged into the wall outlet in the patient's room.The physician was in the patient's room, visiting the patient, and the concentrator started smoking and removed the concentrator from the room.Appears no one was hurt.

Manufacturer Narrative

Device was returned for evaluation, during testing, the uut did not exhibit any signs of smoke or dust internal or external to the unit.Internally, there were no signs of smoke or burns from on the circuit board, capacitor, compressor, or fan.However, the uut did have a defective fan, which affected the cooling in the unit, allowing the unit to overheat and compressor to shut down.When the compressor overheated and shut down, there was no smoke produced.A known properly functioning cooling fan was connected to the circuit board of the unit and rotated properly without issue.This shows that the cooling fan and not the circuit board in the uut was defective, which prevented proper cooling in the unit.The oxygen produced by the uut was within specification at every flow rate.

• Brand Name: COMPANION 5
• Type of Device: CONCENTRATOR, OXYGEN, 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: 6962775
• MDR Text Key: 90657038
• Report Number: 3004972304-2017-00034
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15067005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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