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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL WATER STERILE FOR INHALATION 500ML; HUMIDIFIER, RESPIRATORY GAS,
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VYAIRE MEDICAL WATER STERILE FOR INHALATION 500ML; HUMIDIFIER, RESPIRATORY GAS, Back to Search Results
Catalog Number CN0005
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Bronchospasm (2598)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Any additional information provided by the customer will be included in a follow-up report.At this time, vyaire is awaiting evaluation of the returned device.
 
Event Description
It was reported to vyaire medical that the reported the product smelled like cherries.One patient had experienced bronchospasm as result of the (cherry) scent.Medical intervention was required; they provided breathing treatment and also gave steroids as they were not sure what was happening to the patient.The customer have since stopped using the product from that lot, and had not had any further issues.
 
Manufacturer Narrative
Actual sample was not returned; however a companion sample was evaluated and the reported issue was confirmed.The product met specifications and no issues were identified related to the manufacturing process.A root cause could not be determined.
 
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Brand Name
WATER STERILE FOR INHALATION 500ML
Type of Device
HUMIDIFIER, RESPIRATORY GAS,
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key8097603
MDR Text Key128183874
Report Number3005440755-2018-00001
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K830895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCN0005
Device Lot NumberZI-1806180
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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