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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. VISIONAIRE V; OXYGEN CONCENTRATOR, STATIONARY
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CAIRE INC. VISIONAIRE V; OXYGEN CONCENTRATOR, STATIONARY Back to Search Results
Model Number AS098-101
Device Problem Device Emits Odor (1425)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2017
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
Does not run well, "sounds like it's about to beat itself to death".Plugged unit in and ran, after a few seconds got a "burning wire smell".Unit has 4514 hours.
 
Manufacturer Narrative
The unit was returned for evaluation.Based on the results of this testing, the initial complaint appears to have been caused by a faulty power switch.An internal short in this component caused the rapid power cycling that was originally observed.This also caused excessive heat that was beginning to burn the plastic around the switch.Based on the fact that the unit had been in operation for over 4500 hours at the time of testing, it does not appear that the unit shipped in this condition.It is unclear how the short developed in the switch.A pre-existing flaw may have worsened over time or contamination in the switch may have contributed since there was a large amount of dust and dirt present.
 
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Brand Name
VISIONAIRE V
Type of Device
OXYGEN CONCENTRATOR, STATIONARY
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
MDR Report Key7138044
MDR Text Key95944028
Report Number3004972304-2017-00050
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 Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberAS098-101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Was the Report Sent to FDA? No
Date Manufacturer Received11/21/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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