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

Model Number MICROBLENDER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.The unit was returned to vyaire factory service for evaluation and repair.After performing overhaul repair, the issue was resolved and the device was returned back to the customer operating to manufacturer specifications.

Event Description

The customer reported while using the bird high flow blender series; the unit's fraction of inspired oxygen is out of specifications.The customer reported there is no patient involvement associated with the event.

• Brand Name: BIRD HIGH FLOW BLENDER SERIES
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6995219
• MDR Text Key: 91221300
• Report Number: 2021710-2017-06909
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2017

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
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1