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

Model Number 3100A

Device Problems Failure to Cycle (1142); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The customer reported evaluating the suspect device/ component and determined a component within the power module assembly was burnt.Additionally, the device driver assembly was due for a preventative maintenance replacement per our technical support device history, which was provided to the customer.At this time, vyaire medical has not received the suspect power module component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported this ventilator device stopped oscillating and smelled smoke, while in patient use.The customer stated no patient harm or injury with this event was reported.

Manufacturer Narrative

Vyaire complaint number (b)(4).Results of investigation: the driver assembly was returned for evaluation.Visual inspection of driver found piston diaphragm visibly worn from usage.No additional damage or contamination were noted.A vyaire service technician was not able to duplicate the reported complaint.Likely cause of failure would be attributed to the power module assembly.3100a unit was over 1000 hours past due for its 6k preventive maintenance which could also have contributed to the reported failure.The power module assembly was not returned for investigation.

• 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: 8091748
• MDR Text Key: 127957309
• Report Number: 2021710-2018-09587
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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