MAUDE Adverse Event Report: VYAIRE MEDICAL BLENDER; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	03803T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire complaint #: (b)(4).The vyaire factory service dept.Received the microblender from the customer for repair.The vyaire factory service dept.Duplicated the issue reported by the customer which was isolated to a component failure, specifically the poppet.The poppet was replaced and the microblender was tested.The microblender passed all testing and met all vyaire manufacturer specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The microblender has been returned customer.
Event or Problem Description
It was reported to vyaire that the microblender is alarming while the 2 gases were connected.The customer advised there was no patient involvement associated with this event.
Additional Manufacturer Narrative
Vyaire complaint #: (b)(4).Additional information: g4, g7, h2, h3, h6, h10 results of investigation: the vyaire service dept.Forwarded the suspect component to the vyaire failure analysis lab (fa lab) who performed a failure investigation.The reported issue was duplicated during testing.The o-rings were did not have an adequate amount of lubrication.As only the poppet was received it is unknown whether the poppet sleeve also had inadequate lubrication.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BLENDER
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9344327
• Report Number: 2021710-2019-11049
• Device Sequence Number: 11463418
• Product Code: BZR
• UDI-Device Identifier: 10846446002256
• UDI-Public: (01)10846446002256(11)20190621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Number: 03803T
• Device Catalogue Number: 03803T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1