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U.S. Department of Health and Human Services

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

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CAIRE INC. COMPANION 5; CONCENTRATOR, OXYGEN, STATIONARY Back to Search Results
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.
 
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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 Key6962775
MDR Text Key90657038
Report Number3004972304-2017-00034
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121167
Number of Events Reported1
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 Number15067005
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 Received10/19/2017
Supplement Dates Manufacturer Received09/20/2017
Supplement Dates FDA Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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