MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. SENSORMEDICS HIGH FREQUENCY VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2019

Event Type  malfunction  

Event Description

Mean airway pressure set to 12cmh2o, ventilator alarms when the high alarm is set to 14cmh2o and the low alarm alarms when set to 14 cmh2o not at 12 cmh2o.

• Brand Name: SENSORMEDICS HIGH FREQUENCY VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 9995397
• MDR Text Key: 188849496
• Report Number: 9995397
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Type of Device Usage: N
• Patient Sequence Number: 1