MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100 A

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire medical has not received the suspect device.Once received and evaluated, a follow-up medwatch report will be submitted.

Event Description

It was reported to vyaire medical that the ventilator was in use on a patient, and it seemed to lose pressure and the driver alarmed and stopped.The patient was manually ventilated with no issues r harm and placed on another ventilator.

Manufacturer Narrative

Vyaire medical's field service representative was able to resolve the customer's reported issue by installing 12k kit and driver.Calibrated and verified performance.The 3100a ventilator passed all performance checks.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9513184
• MDR Text Key: 173289572
• Report Number: 2021710-2019-11200
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention