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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY

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CAIRE INC. VISIONAIRE 5 CONCENTRATOR, OXYGEN, STATIONARY Back to Search Results
Model Number AS098-5
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Event Description

The following incident was reported to caire by a distributor. During a patient visit by one of our technicians, this incident was noticed. The patient has a nosebleed every time that she uses the concentrator. It is not linked to a specific device, as she has the same problem when she uses the portable devices. The technician assumed that this condition is caused by the oxygen use. The patient already has a humidifier, prescription of 3 l/min 16 hours/day. The patient was advised to contact her general practitioner to see if and how the situation could be improved.

 
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Brand NameVISIONAIRE 5
Type of DeviceCONCENTRATOR, OXYGEN, 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
7707217700
MDR Report Key9935840
Report Number3004972304-2020-00010
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberAS098-5
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/08/2020 Patient Sequence Number: 1
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