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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION
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P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION Back to Search Results
Model Number LOW FLOW BLENDER
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/20/2021
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
The customer reported to vyaire medical that the low flow blender ventilator has a incident with the patient and cause patient harm.At this time there is no information regarding what harm happened to the patient as well as intervention done.
 
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Brand Name
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
Common Device Name
MIXER, BREATHING GASES, ANESTHESIA INHALATION
MDR Report Key12330584
Report Number2021710-2021-14372
Device Sequence Number4712988
Product Code BZR
UDI-Device Identifier10190752174610
UDI-Public(01)10190752174610
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
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 health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/20/2021
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 NumberLOW FLOW BLENDER
Device Catalogue Number11392
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/20/2021
Initial Report FDA Received Date08/17/2021
Was Device Evaluated by Manufacturer? (Y/N) No
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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