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

Model Number	768901-RNT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.A field service representative (fsr) was able to verify the customer's reported issue.Bench testing revealed a faulty needle valve.The service technician replaced the needle valve and the reported issue was resolved.The device passed all testing and met all vyaire manufacturer specifications.
Event or Problem Description
It was reported to vyaire that the 3100a ventilator experienced an issue with the mean airway pressure (map) jumping all over the place.The customer confirmed that there was no patient involvement associated with the reported issue.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8493606
• Report Number: 2021710-2019-10096
• Device Sequence Number: 1651366
• Product Code: CBK
• UDI-Device Identifier: 20846446003397
• UDI-Public: (01)20846446003397(11)20160126
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 768901-RNT
• Device Catalogue Number: 768901-RNT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1