MAUDE Adverse Event Report: VYAIRE MEDICAL BIRD HIGH FLOW BLENDER SERIES; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	BLENDER
Medical Device Problem Code	Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.The suspect device was returned to vyaire's factory service for evaluation and repair.Factory service was able to confirm the reported event and reported the device is out of calibration.After re-calibrating the device, the issue was resolved.Factory service returned the device back to specifications.
Event or Problem Description
The customer reported while using the high flow microblender; the fraction of inspired oxygen (fio2) is out of specifications at 30%.The customer reported messing with the knob, adjusting the seat, and now it is all out of specifications.The customer reported to not being trained to perform overhaul of the device and wanted to return the device to vyaire's factory service for evaluation/repair.The customer reported there is no patient involvement associated with the event.

• Brand Name: BIRD HIGH FLOW BLENDER 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: 8376007
• Report Number: 2021710-2019-09943
• Device Sequence Number: 312471
• Product Code: BZR
• UDI-Device Identifier: 10846446002348
• UDI-Public: (01)10846446002348
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: BLENDER
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1