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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL BIRD HIGH FLOW BLENDER SERIES; MIXER, BREATHING GASES, ANESTHESIA INHALATION
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VYAIRE MEDICAL BIRD HIGH FLOW BLENDER SERIES; MIXER, BREATHING GASES, ANESTHESIA INHALATION Back to Search Results
Model Number BLENDER
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been received by vyaire for evaluation/repair.
 
Event Description
The customer reported while using the high flow microblender; the oxygen dial is inaccurate.The customer performed troubleshooting, but the issue went unresolved.The customer reported there is no patient involvement associated with the event.
 
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Brand Name
BIRD HIGH FLOW BLENDER SERIES
Type of Device
MIXER, BREATHING GASES, ANESTHESIA INHALATION
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
stanley tan
22745 savi ranch pkwy
yorba linda, CA 92887
7149193324
MDR Report Key8185211
MDR Text Key131044345
Report Number2021710-2018-09698
Device Sequence Number1
Product Code BZR
UDI-Device Identifier10846446002348
UDI-Public(01)10846446002348
Combination Product (y/n)N
Reporter Country CodeQA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBLENDER
Device Catalogue Number03800A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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