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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 Consequences Or Impact To Patient (2199)
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
Patient called aerocare saying that the unit was smoking and sparking.
 
Manufacturer Narrative
Unit was returned for evaluation.The smoking and sparking described by the adverse event form could not be replicated while testing the companion 5 oxygen concentrator in question.Visual inspections and functional tests showed that the concentrator test unit is undamaged and it operates within its functional specifications, both in its output flow and in its oxygen purity.No abnormal behaviors or alarms were observed.
 
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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
MDR Report Key7409672
MDR Text Key105277389
Report Number3004972304-2018-00007
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K121167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/17/2019
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? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/12/2018
Initial Date FDA Received04/09/2018
Supplement Dates Manufacturer Received03/12/2018
Supplement Dates FDA Received07/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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