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

Model Number BLENDER

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, vyaire has not received the suspect device for evaluation.

Event Description

The customer reported while using the bird high flow blender; the device has an alarm failure.The customer reported there is no patient involvement associated with the event.

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect blender assembly for investigation.An evaluation of the component could be confirmed and duplicated.The o-ring on the bypass assembly was worn.The worn o-rings were visually inspected under a microscope and found that the edges of both o-rings are split causing an uneven surface.This was causing the poppet to not react properly.

• 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: 7126612
• MDR Text Key: 95182387
• Report Number: 2021710-2017-07156
• 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,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BLENDER
• Device Catalogue Number: 03800A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2001
• 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