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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROBLENDER; MIXER,BREATHING GASES,ANESTHESIA INHALATION
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MICROBLENDER; MIXER,BREATHING GASES,ANESTHESIA INHALATION Back to Search Results
Model Number MICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event or Problem Description
A vyaire representative reported the unit has a leak on the micoblender component.The vyaire representative reported there was no patient involvement associated with the reported event.
 
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Brand Name
MICROBLENDER
Common Device Name
MIXER,BREATHING GASES,ANESTHESIA INHALATION
MDR Report Key12515139
Report Number2021710-2021-14469
Device Sequence Number1101459
Product Code BZR
UDI-Device Identifier10846446002225
UDI-Public(01)10846446002225(11)20111118
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K883038
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO
Device Catalogue Number10040A
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2021
Initial Report FDA Received Date09/22/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured11/18/2011
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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