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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 AS098-101
Device Problem Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2017
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
Patient claimed that the unit was loud.Unit brought to shop.Once opened up the customer saw that the wires were melted through and had made contact with the compressor.The customer stated that the unit produced o2 @ 95%.The only issue was the noise and vibration coming from the unit.Ran with different compressor and the unit ran normal and produced 95% o2.The problematic compressor has been placed back into unit prior to shipping.
 
Manufacturer Narrative
Device was returned for evaluation.The user complaint regarding loud sounds emanating from the unit and the damage found on the compressor by the costumer can be explained by the missing mounting spring on the compressor base.An unstable compressor could vibrate against the concentrator's casing, causing loud noises, and it could also vibrate against the compressor leads, causing the abrasive damage to the lead wires.It is unclear how the mounting spring became loose and how it lodged itself in the compressor enclosure padding.
 
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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 Key7052892
MDR Text Key93301523
Report Number3004972304-2017-00042
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 distributor
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 NumberAS098-101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2017
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/24/2017
Initial Date FDA Received11/22/2017
Supplement Dates Manufacturer Received10/24/2017
Supplement Dates FDA Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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