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

Model Number	3100A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire evaluate device onsite found out vent has no support arm.The circuit was disconnected where the support arm would be located.Excess water in the circuit cause map (main airway pressure) fluctuations.The customer was using low flow blender which is not recommended for ventilator use.Vyaire replaced circuit and retested system no other problems noted.The power module was replaced and performed 7 year pm.Completed performance test on the ventilator no other problems noted.
Event or Problem Description
The customer reported that the 3100a map (main airway pressure) was fluctuating and the amp reading is 2.The device was running on a patient and was transferred to another ventilator.Customer confirmed no patient harm in this reported event.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9780500
• Report Number: 2021710-2020-11481
• Device Sequence Number: 2788132
• Product Code: LSZ
• UDI-Device Identifier: 10846446003024
• UDI-Public: (01)10846446003024(11)20131126
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901-RFB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention