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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEB ADAPTER F/1000ML BOTTLE 24/CS; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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NEB ADAPTER F/1000ML BOTTLE 24/CS; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number NEB ADAPTER F/1000ML BOTTLE 24/CS
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported a clogged nebulizer cap that wouldn't nebulize, and apparently a couple others have been reported as being sluggish in terms of aerosol output/sputtering.
 
Manufacturer Narrative
The customer sent one opened sample part number (b)(4).With lot number 0004170351 within original package for the investigation.Sample was inspected according to pqas ck0005 etal performing a vacuum test, diameter verification, bar gage verification, cap - bottle installation test, getting acceptable results.Therefore the defect reported by the customer was not confirmed.
 
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Brand Name
NEB ADAPTER F/1000ML BOTTLE 24/CS
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
MDR Report Key11721220
MDR Text Key258435128
Report Number8030673-2021-00164
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10885403180477
UDI-Public(01)10885403180477(10)0004170351
Combination Product (y/n)N
PMA/PMN Number
K112840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNEB ADAPTER F/1000ML BOTTLE 24/CS
Device Catalogue Number3D0868
Device Lot Number0004170351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2021
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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