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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL NEBULIZER JET 28% 350ML 28-98% FIO2; O2 THERAPY
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VYAIRE MEDICAL NEBULIZER JET 28% 350ML 28-98% FIO2; O2 THERAPY Back to Search Results
Catalog Number 5007P
Device Problem Insufficient Information (3190)
Patient Problem Respiratory Distress (2045)
Event Date 12/19/2018
Event Type  Injury  
Manufacturer Narrative
Presently, the suspect component is not available for return.Therefore, no further evaluation can be completed at this time.
 
Event Description
The customer reported that the nebulizer did not create any humidity and needed to be replaced with another that did work properly.The patient ended up needing drug intervention to help manage the airway.
 
Manufacturer Narrative
(b)(4).Device evaluation: d4, d10, g4, g7, h2, h3, h6, h10.The suspect device was received by our vyaire quality investigation team.The evaluation determined no issues were observed with the sample received for valuation.Additionally, no issues were found with our current process.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
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Brand Name
NEBULIZER JET 28% 350ML 28-98% FIO2
Type of Device
O2 THERAPY
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key8301732
MDR Text Key134931841
Report Number8030673-2019-00027
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K760585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5007P
Device Lot Number0001133882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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