MAUDE Adverse Event Report: VYAIRE MEDICAL ULTRA MICROBLENDER SERIES; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	BLENDER
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device for evaluation.
Event or Problem Description
The customer reported while using the blender, the device developed a very large leak.The customer reported the issue occurred after one use and they cannot trace where the leak is coming from.The issue occurred during patient-use.The customer reported there is no patient consequence associated with the event.
Additional Manufacturer Narrative
The vyaire failure analysis laboratory received the suspect device for investigation.Aluminum burr is not allowing a flush seal of o-ring on attached right-side flow meter and causing a leak.This issue will be internally investigated within vyaire.

• Brand Name: ULTRA MICROBLENDER SERIES
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8771882
• Report Number: 2021710-2019-10505
• Device Sequence Number: 1708562
• Product Code: BZR
• UDI-Device Identifier: 10846446002225
• UDI-Public: (01)10846446002225
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BLENDER
• Device Catalogue Number: 10040A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention