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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 AS098-5
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
The unit has not been returned for evaluation.If any new information is discovered, a follow-up report will be submitted.
 
Event Description
Concentrator stopped functioning.User smelled 'burn' odor.User taken into hospital, reason unknown.User deceased 2 weeks later due to unknown reason.The unit will be collected and returned for inspection.
 
Manufacturer Narrative
Device was returned for an evaluation.Unit did not run due to faulty compressor, however all audio and visual alarms operated as intended.
 
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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
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
MDR Report Key7229805
MDR Text Key98750624
Report Number3004972304-2018-00001
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K872534
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberAS098-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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