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

Model Number BLENDER

Device Problem Delayed Alarm (1011)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The suspect device was received by vyaire's factory service for evaluation.Device evaluation is anticipated, but not yet begun.Once final investigation is complete, a follow-up report will be submitted.

Event Description

The customer reported while using the microblender; the alarm is slow to react when testing.The customer reported there is no patient involvement associated with the event.

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect component for investigation.A visual inspection of the assembly did not show signs of physical damage.The reported event could be confirmed and duplicated.The root cause was identified to be debris on the o-ring of bypass alarm poppet.This issue will be internally investigated within vyaire.

• Brand Name: MICROBLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8487552
• MDR Text Key: 141060915
• Report Number: 2021710-2019-10084
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 10846446001990
• UDI-Public: (01)10846446001990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973646
• 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: 05/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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: 15510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• 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