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

Model Number	766897
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the suspect bellows water trap component item (b)(4) is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect bellows water trap 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 or Problem Description
The customer reported a low mean airway pressure setting, while in patient use on an oscillator device.The customer reported trouble shooting and found the bellows water trap (b)(4) consumable item, was leaking water from the drain component.The customer stated the patient was placed on an alternate device and no patient compromise was associated with this event.

• Brand Name: 3100 HFOV
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8348313
• Report Number: 2021710-2019-09892
• Device Sequence Number: 13920043
• Product Code: LSZ
• UDI-Device Identifier: 20846446003403
• UDI-Public: (01)20846446003403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/24/2019

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: 766897
• Device Catalogue Number: 766897
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention