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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. VISIONAIRE; OXYGEN CONCENTRATOR, STATIONARY
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CAIRE INC. VISIONAIRE; OXYGEN CONCENTRATOR, STATIONARY Back to Search Results
Model Number AS098-4U
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
The unit has been returned for evaluation.If any new information is discovered, a followup report will be submitted.
 
Event Description
Customer report sieve dusting while using the machine.Made him feel really bad and coughing a lot.
 
Manufacturer Narrative
Unit was returned for evaluation.The dusting described by the adverse event form could not be detected while testing the visionaire oxygen concentrator in question.Visual inspections of the outside and inside of the unit did not find any damage or any accumulations of dust.Additionally, functional testing 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 during extended periods of use.
 
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Brand Name
VISIONAIRE
Type of Device
OXYGEN CONCENTRATOR, STATIONARY
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
MDR Report Key7470398
MDR Text Key106855393
Report Number3004972304-2018-00011
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K872534
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberAS098-4U
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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