MAUDE Adverse Event Report: VYAIRE MEDICAL 3100A VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Decrease in Pressure (1490)

Patient Problem No Information (3190)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect ventilator device is available for analysis and an onsite service by a vyaire field service representative has been scheduled.Vyaire will include the field service report and the device/component evaluation in a follow-up report once the final evaluation is completed.

Event Description

The customer reported an unstable mean airway pressure (map) and loud noise, while in patient use on this oscillator device.No known reported patient harm or injury with this event by the customer.

Manufacturer Narrative

Results of investigation: a vyaire field service representative was able to verify the customer's reported issue.However, it was found that the found hospital was using pressure limit not pressure adjust.No issue was found with the ventilator.The device passed all testing and met all vyaire manufacturer specifications.

• Brand Name: 3100A VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: 8287011
• MDR Text Key: 134403505
• Report Number: 2021710-2019-09822
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2011
• 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
• Patient Outcome(s): Required Intervention